Breast / Chinese Herbal Medicine / Colon /
Liver / Lung /NPC /Prostate/ Renal /Supportive Care / SYM

Breast Cancer

(BRE002) A randomized trial of high-dose epirubicin and cyclophosphamide x 3 supported by peripheral blood projector cells versus anthracycline and cyclophosphamide x 4 followed by cyclophosphamide, methotrexate & 5-fluorouracil as adjuvant treatment for high risk operable stage II and stage III breast cancer in premenopausal and young postmenopausal (<65 yrs) patients. (Collaboration with IBCSG)

Eligibility: Premenopausal and young postmenopausal (<65years) patients with histologically proven, high risk operable breast cancer as defined by the following groups: >=10 involved axillary lymph nodes, ER negative tumors with >=5 involved axillary lymph nodes
Objectives: To evaluate the efficacy of 3 cycles of dose-intensive epirubicin and cyclophosphamide supported by filgrastim-mobilised peripheral blood progenitor cell and filgrastim in women with high risk, operable stage II and stage III breast cancer. The increase in total dose and dose intensity of chemotherapy is hypothesized to increase tumor cell kill. Compare the overall survival, Q-TWiST, QOL, systemic disease free survival duration
Status: Follow Up
Chair: Prof. Winnie Yeo

(BRE005) A randomized double-blind trial in postmenopausal women with primary breast cancer who had received TMV for 2-3 years. (Sponsored by Pharmacia-Upjohn)

Eligibility: Postmenopausal women patients who have received tamoxifen for 2 to 3 years, histologically or cytologically proven unilateral operable breast adenocarcinoma, after adequate therapy for primary disease, primary tumour ER status positive or ER unknown
Objectives: Endpoints are disease free survival and overall survival after 5 years of tamoxifen or in adjuvant of exemestane, the nominal timepoint of interest is one year completion of trial therapy (6 years after breast cancer diagnosis)
Status: Follow Up
Chair: Prof. Winnie Yeo

(BRE008) A multicenter Phase III randomized trial comparing docetaxel in combination with doxorubincin and cyclophosphamide (TAC) versus doxorubincin and cyclophosphamide followed by docetaxel (AC->T)as adjuvant treatment of operable breast cancer her2neu negative patients with positive axillary lymph nodes-BCIRG trial. (Sponsored by Breast Cancer International Research Group (BCIRG)/Aventis Pharma)

Eligibility: Histologically proven breast cancer patients within 60 days after definitive surgical treatment with axillary lymph node dissection for operable breast cancer (T1-3, clinical N0-1, M0), with age 18-70. Tumor must show negative her2neu proto-oncogence overexpression by FISH.
Objectives: To compare disease-free survival after treatment. To compare overall survival, toxicity and quality of life between arms. To evaluate pathologic and molecular markers for predicting efficacy.
Status: Follow Up
Chair: Prof. Winnie Yeo

(BRE015) Open-label study of bevacizumab(AVASTIN®)plus taxane monotherapy or in combination for the first-line treatment of patients with locally recurrent or metastatic breast cancer –ATHENA study (Sponsored by F.Hoffmann-La Roche LTD)

Eligibility: Patient who is confirmed with local recurrent or metastatic disease and who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent. Patient should have adequate hematological function, liver and renal functions.
Objectives: To assess the efficacy of bevacizumab when combined with taxane monotherapy or in combination as first line treatment of patients with local recurrent or metastatic breast cancer as measured by time to disease progression and overall survival.
Status: Follow Up
Chair: Dr WM Ho

(BRE019) A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2- Positive Metastatic Breast Cancer

Eligibility: Histologically proven adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Patient must have HER2-positive disease, over 18 years old, with normal heart function, ECOG status 0 or 1 and adequate hematological, liver and renal function.
Objectives: To compare progression-free survival (PFS) based on tumor assessments by an independent review facility (IRF) between patients in the two treatment arms: placebo + trastuzumab + docetaxel vs. pertuzumab + trastuzumab + docetaxel.
Status: Active
Chair: Prof Winnie Yeo

(BRE020) An international multi-centre open-label 2-arm phase III trial of adjuvant bevacizumab in “triple negative” breast cancer

Eligibility: The patient must have presented with an operable primary invasive carcinoma of the breast. The primary tumour must be identified and by clinical and pathologic evaluation be T1a-T3. Central laboratory testing of the primary invasive tumour must confirm HER2 negativity and the endocrine receptor expression (ER and PgR) must be either negative or low. Patients must have undergone either breast conservation surgery or a total mastectomy and the surgical margins of the resected specimen must be histologically free of invasive adenocarcinoma and ductal carcinoma-in-situ.
Objectives: Primary: To compare Invasive Disease- Free Survival (IDFS) of patients randomized to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year bevacizumab. Secondary: To compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease-Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomized to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab. Identification of a biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment. Evaluate the safety and tolerability of bevacizumab
Status: Active
Chair: Dr. Ho Wing Ming

(BRE021) A Multicentre Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab

Eligibility: The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. The breast cancer must be HER2-positive based on local and central testing. All of the following staging criteria must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
Objectives: The BETH Trial will determine the value of adding bevacizumab to regimens of chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer
Status: Active
Chair: Prof. Winnie Yeo

(BRE022) A randomised Phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy

Eligibility: Patients with histologically confirmed and documented, HER2-negative metastatic adenocarcinoma of the breast, who are candidates for taxane-based chemotherapy. Documented ER/PRgR status. Previous chemotherapy for metastatic breast cancer is not allowed. Prior hormone therapy for metastatic disease is allowed. Prior adjuvant/neoadjuvant chemotherapy within 6 months prior to first study treatment administration is not allowed.
Objectives: Primary Objective: Evaluate whether maintenance therapy with bevacizumab plus capecitabine compared to bevacizumab alone, can further increase progressive free survival in patients showing objective response or stable disease following initial therapy with bevacizumab plus doxetaxel. Secondary Objectives: Evaluate during the initial treatment phase: Overall response rate. Clinical benefit rate. Safety and tolerability. Evaluate during the maintenance treatment phase: Overall response rate. Clinical benefit rate. Quality of life. Time-to-progression. Overall survival. Safety and tolerability.
Status: Active
Chair: Prof. Winnie Yeo

Colon Cancer

(COL003) Pre and Post-Operative Chemotherapy with Oxaliplatin 5FU/LV versus Surgery alone in Resectable Liver Metastases from Colorectal Origin - Phase III Study. (Collaboration with EORTC)

Eligibility: Presence of potentially resectable liver metastases of colorectal cancer without detectable extra-hepatic tumor, WHO performance status <= 2 (Karnofsky >= 60%), allow previous adjuvant chemotherapy for primary cancer except oxaliplatin.
Objectives: To compare the two arms with respect to progression free survival, overall survival, tumor resectability, and tumor response.
Status: Follow Up
Chair: Prof. Anthony Chan

(COL007) A2x2 factorial randomized phase III study of intermittent oral Capecitabine in combination with intravenous Oxaliplatin (Q3W)(“XELOX”) with/without intravenous Bevacizumab (Q3W) versus bolus and continuous infusion Fluorouracil/ intravenous Leucovorin with intravenous Oxaliplatin (Q2W) (“FOLFOX-4) with/without intravenous Bevacizumab (Q2W) as first-line treatment for patients with metastatic colorectal cancer.

Eligibility: Male and female outpatients ³18 years, ECOG performance status £1, with histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease. Patients must have measurable lesions according to RECIST criteria, must not have previously received systemic treatment for advanced or metastatic disease. Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
Objectives: To demonstrate that, in terms of time to tumor progression or death (TTP), for patients with inoperable locally advanced or metastatic colorectal carcinoma who have not previously received systemic treatment for metastatic disease 1) the combination of Capecitabine and Oxaliplatin (XELOX) with/without bevacizumab is at least equivalent to the combination of Fluorouracil plus Leucovorin and Oxaliplatin (FOLFOX-4) with/without bevacizumab, and 2) bevacizumab in combination with chemotherapy (XELOX+A/ FOLFOX-4+A) is superior to chemotherapy (XELOX/FOLFOX-4) alone.
Status: Follow Up
Chair: Prof. Anthony Chan

(COL008) Open, randomized, controlled, multicenter phase III study comparing 5-FU/FA plus irinotecan plus cetuximab versus 5-FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal carcinoma (CRYSTAL study) (Sponsored by Merck KGaA)

Eligibility: Patient with histologically documented colorectal cancer with is EGFR-positive, age 18 years or over, inoperable metastatic disease with ECOG performance status of 0-2 at study entry and with reasonable hematology, liver and renal functions.
Objectives: To assess whether the progression-free survival (PFS) time under 5-FU/FA plus irinotecan plus cetuximab is longer than that under 5-FU/FA plus irinotecan as first-line treatment for EGFR-expressing metastatic CRC.
Status: Follow Up
Chair: Prof. Anthony Chan

(COL009) A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma
(The AVANT Study) (Sponsored by F HOFFMANN-LA ROCHE AG)

Eligibility: Male and female outpatients 18 years of age or over with histological confirmed colon carcinoma who have had potentially curative surgery not less than 4 and not more than 8 weeks prior to randomization. Patient must not have previous treatment for any malignancy. Patient must have ECOG performance status 0 or 1 with no evidence of remaining tumor.
Objectives: 1) To demonstrate that the combination of bevacizumab and FOLFOX-4 is superior to FOLFOX-4 alone in terms of disease-free survival in chemotherapy-naïve patients who underwent surgery with curative intent for colon carcinoma. 2) To demonstrate that the combination of bevacizumab and XELOX is superior to FOLFOX-4 alone in terms of disease-free survival in chemotherapy-na?ve patients who underwent surgery with curative intent for colon carcinoma.
Status: Follow Up
Chair: Prof. Anthony Chan

Liver Cancer

(HCC016) A Phase 3 Randomized Study to Evaluate Survival of Patients Treated with Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) (Sponsored by Light Sciences Oncology)

Eligibility: Histologically evidence of HCC or two different imaging techniques with characteristics that suggest HCC or combination of one imaging technique that suggests HCC and serum AFP level >400ng/mL. Patient must have less than 6 lesions and the disease are not for complete surgical resection. Moreover, patient should be with ECOG =2 and adequate haematologic, renal and hepatic function.
Objectives: To assess the survival of a subset of patients in the Litx group who received Litx treatment followed by the standard of care versus patients in the standard of care group for the treatment of unresectable hepatocellular carcinoma (HCC).
Status: Follow Up
Chair: Prof. Tony Mok

(HCC017) A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) with Lipiodol-Ethanol Mixture (LEM) versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma (HCC).

Eligibility: Histologically or cytologically proven unresectable HCC; massive expansive tumor type with measurable lesion on CT scan with reasonable tumor size. Patient should also have good performance status and acceptable liver and renal functions.
Objectives: To evaluate survival (overall and progression free survival) of patients with localized unresectable HCC treated with TEA with LEM as compared to TACE.
Status: Active
Chair: Dr. Simon Yu, Prof. Winnie Yeo

(HCC020) A Multinational, Randomized, Open-Label, Phase 3 Study of Sunitinib Malate versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Eligibility: Histologically or cytologically proven unresectable HCC; with measurable lesion on CT scan with reasonable tumor size. Patient should also have good performance status and acceptable liver and renal functions.
Objectives: To demonstrate that overall survival on Sunitinib is superior or equivalent to overall survival on Sorafenib in patients with advanced hepatocellular carcinoma.
Status: Active
Chair: Prof. Winnie Yeo

Lung Cancer

(LUN021) An open label, randomized, parallel group, multicentre, phase III study to assess efficacy, safety and tolerability of Gefitinib versus carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced stage IIIb or IV NSCLC in Asia (Sponsored by AstraZeneca group of companies)

Eligibility:Histological proven stage III or IV non-small cell lung cancer (with adenocarcinoma histology) patients with age >=18 years and must have no prior chemotherapy for advanced NSCLC.
Objectives: To compare gefitinib with carboplatin/placlitaxel doublet chemotherapy given as first line treatment in terms of progression free survival
To compare the randomized treatment arms in terms of overall survival.
To compare gefitinib with carboplatin/placlitaxel doublet chemotherapy given as first line treatment in terms of objective response rate.
Status: Follow Up
Chair: Prof. Tony Mok

(LUN026) Open label study of AVASTIN® (bevacizumab) in combination with platinum containing chemotherapy as first line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer
(SAIL – Safety of Avastin In Lung)

Eligibility: Patients with age ³18 years. Histological proven locally advanced or metastatic NSCLC other than squamous cell and had no prior palliative chemotherapy.
Objectives: To assess the safety profile of Avastin when combined with chemotherapy as 1st line treatment of advanced or recurrent non-squamous NSCLC.
To assess the efficacy of Avastin as measured by time to disease progression and overall survival.
To assess the safety of Avastin in patients who develop CNS metastases during and for 6 months following the treatment period.
Status: Follow Up
Chair: Prof. Tony Mok

(LUN027) A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease (START Study)

Eligibility: Patients with age ³18 years.Histological proven stage III NSCLC and achieved stable disease or objective response after primary chemo-radiotherapy.
Objectives: To compare survival duration of all randomized subjects by treatment arm. TTSP is as measured by LCSS and as determined by the investigator. One-, two-, three-year survival and safety.
Status: Active
Chair: Prof. Tony Mok

(LUN028) A phase III, International, Randomised, Double-Blind, Parallel-Group, Multi-Centre to Assess the Efficacy of ZD6474 (ZACTIMA) Plus Best Supportive care Versus Placebo Plus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

Eligibility: Female or male with age ³18 years. Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIB-IV) on entry into study. Failure of prior therapy (during or after treatment) with an EGFR tyrosine kinase inhibitor (e.g. erlotinib or gefitinib either radiological documentation of disease progression or due to toxocity). At least one but no more than two prior chemotherapy regimens.
Objectives: To demonstrate an improvement in overall survival for ZD6474 plus best supportive care (BSC) compared with placebo plus BSC in patients with locally advanced or metastatic NSCLC after prior therapy with an EGFR TKI.
Status: Follow Up
Chair: Prof. Tony Mok

(LUN031) A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung cancer

Eligibility: Patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC. Written informed consents prior to protocol-specific procedures. Patient is >=18 years. MAGE-A3 positive patient’s tumor. Surgery for tumor resection is anatomical, involving at least a lobectomy or a sleeve lobectomy. Mediastinal lymph node sampling is done according to study protocol guidelines.
Objectives: Primary Objectives: Clinical efficacy of recMAGE-A3 + AS15 versus placebo. Objective A: Efficacy in the overall population (CT and no-CT);
Objective B: Efficacy in the no-CT population. Secondary Objectives: Other clinical and biological indicators of safety and efficacy. Translational research: gene expression profile, biomarkers. Status: Active
Chair: Prof. Tony Mok

(LUN033) A  Multicenter, Randomized, DB, Controlled Phase 3, Efficacy & Safety Study of Sunitinib (SU011248) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Treated with Erlotinib (Pfizer)

Eligibility:Patient with age >=18 years old.Histological or cytological confirmation of NSCLC and had prior treatment with 1 or 2 chemotherapy regimens for advanced disease.
Objectives: Primary: Overall Survival (OS).Secondary: Progression Free Survival (PFS), Objective Response Rate (ORR).Duration of Response (DR), 1-year Survival, Type, incidence, severity, timing, seriousness, and relatedness of AE and lab abnormalities, EQ-5D
Status: Follow Up
Chair: Prof. Tony Mok

(LUN038) A Randomized, Open Label, Phase 3 Trial of CP-751,871 in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in patients with Non-small cell lung cancer

Eligibility: Histologically or cytologically confirmed diagnosis of non-small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma. Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease. No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed >= 12 months prior to randomization. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization.
Objectives: Primary: Determine whether the addition of CP-751,871, an IGF-1R inhibitor, in combination with paclitaxel plus carboplatin prolongs survival in patients with non-adenocarcinoma NSCLC.Secondary: Assess progression free survival in each arm. Evaluate the safety and tolerability of CP-751,871 in combination with paclitaxel and carboplatin. Assess the overall response rate in each arm. Assess health-related quality of life outcomes and health states in both treatment arms. Collect pharmacokinetic data of CP-751,871 for population pharmacokinetic meta-analysis. Monitor for the occurrence of anti-drug antibody in response to CP-751,871 treatment. Explore the association pretreatment IGF-1 and change in IGF-1 with survival. Collection of anonymized samples for molecular profiling.
Status: Active
Chair: Prof. Tony Mok

(LUN041) Multicenter, randomized, double-blind, phase III trail to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIIB/IV or recurrent NSCLC after failure of first line chemotherapy

Eligibility: Inclusion criteria: Histologically or cytologically confirmed stage IIIB, IV or recurrent NSCLC (non aquamous histologies). ECOG 0 or 1. Relapse or failure of one first line chemotherapy.
Exclusion: Previous therapy with other vegfr inhibitors or premetrexed for treatment NSCLC. Significant weight loss >10% within the past 6 weeks prior to treatment in the present trial. Active or chronic hep C and/or B infection. Significant cardiovascular diseases. History of major thrombotic or clinically relevant major bleeding event in the past 6 months.
Objectives: Primary endpoint: Progression free survival. Secondary endpoint: Overall survival. Tumor response. Incidence and intensity of AE. Clinical improvement. Changes in safety laboratory parameters. QOL measured by standardized questionnaires. PK of BIBF 1120.
Status: Active
Chair: Dr. KC Lam

(LUN042) A randomised, placebo-controlled, double-blind phase III study of intercalated of Tarceva® (erlotinib) or placebo with gemcitabine/platinum as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer (NSCLC)

Eligibility: Inclusion criteria: Patients with histological/cytological documented advanced or recurrent stage IIIB or stage IV NSCLC. ECOG 0 or 1. No history of exposure to agents directed at the HER axis. No previous chemotherapy with systemic anti-tumor therapy for advanced disease.
Objectives: Primary endpoint: To compare progression free survival. Secondary endpoint: To compare PFS in subgroups characterized by adenocarcinoma, never smoked, EGFR and KRAS mutation status, EGFR protein expression status and EGFR gene copy status. To compare overall survival in all patients and subgroups characterized by adenocarcinoma, never smoked, EGFR and KRAS mutation status, EGFR protein expression status and EGFR gene copy status. To compare non-progression rate at 16 weeks. To compare objective response rate. To compare duration of response. To compare time to progression. To evaluate the safety profile using NCI CTC AE. To compare QOL.
Status: Active
Chair: Prof. Tony Mok

Nasopharyngeal Carcinoma

(NPC006) Impact on Salivary gland Function by Intensity-Modulated Radiation Therapy in the treatment of nasopharynx cancer: A Prospective Randomized Trial

Eligibility: Patients with histologically proven of NPC, and have treatment-naïve NPC. No evidence of distant metastasis. Staging: T1/T2a/T2b (unilateral parapharyngeal disease) and N0/N1/N2 (excluded bilateral level I/II nodal involvement). ECOG grade 0 - 1.
Objectives: To compare the rates of delayed xerostomia in early-stage nasopharynz cancer patients treated by either Intensity-Modulated radiation therapy or conventional radiation therapy.
Status: Follow-up
Chair: Prof. SF Leung, Dr. Michael KM Kam

(NPC017) A multi-center prospective randomized phase III trial to determine the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in nasopharyngeal carcinoma patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin (NPC-0502 Trial)

Eligibility: Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice. A histological diagnosis of NPC must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization. Loco-regional advanced NPC UICC/AJCC Stages IIB, III, IVA or IVB. No evidence of distant metastases in the staging work up at diagnosis. Must have detectable plasma EBV-DNA (> 0 copies/ml) at 6-8 weeks after completion of primary RT or chemo-RT. No clinical evidence of persistent loco-regional disease after primary treatment. Performance status of ECOG grade 0 or 1. Patients must have adequate organ and marrow function as defined below: leukocytes >= 3,000/L; absolute neutrophil count >= 1,500/L; platelets >= 100,000/L; total bilirubin <= 1.5 X institutional upper limit of normal; AST(SGOT) / ALT(SGPT) <= 2.5 X institutional upper limit of normal; Creatinine clearance >=50 ml/min
Objectives: To study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in nasopharyngeal carcinoma (NPC) patients with elevated plasma EBV DNA following primary radiotherapy with or without concurrent cisplatin.
Status: Active
Chair: Prof. Anthony Chan

(NPC018) Randomized trial to evaluate the therapeutic gain by changing the chemoradiotherapy from concurrent-adjuvant to induction-concurrent sequence, and the radiotherapy from conventional to accelerated fractionation for advanced nasopharyngeal carcinoma. (NPC-0501 Trial)

Eligibility: Histologically proven nasopharyngeal carcinoma for primary treatment with radical intent. Non-keratinizing or undifferentiated type (i.e. exclude WHO Type I squamous cell carcinoma or adenocarcinoma). Stage III-IVB (by AJCC/UICC 6th edition). Age > 18 to < 70 years. Satisfactory performance status: < 2 by ECOG System. Adequate marrow& renal function. No pregnancy or lactation for females of reproductive age. No Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. No history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). No Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
Objectives: The objective of this study is to further improve the therapeutic gain of concurrent chemoradiotherapy (CRT) for Stage III-IVB nasopharyngeal carcinoma (NPC). All treatment arms use Cisplatin in concurrence with radiotherapy as the core treatment. Primary objectives include
• Comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil (PF-P vs P-PF);
• Comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil (PX-P vs P-PF);
• Comparing accelerated fractionation versus conventional fractionation (AF vs CF).
Secondary objectives include
• Comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil (PF-P vs PX-P)
Status: Active
Chair: Prof. Anthony Chan

Prostate

(PST003) A Phase III, Randomised, Double-blind Study to Assess the Efficacy and Safety of 10mg ZD4054 versus Placebo in Patients with Hormone-resistant Prostate Cancer and Bone Metastasis who are Pain Free or Mildly Symptomatic

Eligibility: Male 18+ years. Adenocarcinoma of the prostate. Bone metastasis on radionuclide bone scan. Patient must have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior (AP) or posteroanterior (PA) view. Patients with <= 3 lesions seen on bone scan will require a CT scan, MRI or x-Ray to confirm. Biochemical progression documented while the pt is castrate. Surgically castrated or continuously medically castrated with serum testosterone <= 2.4 nmol/L (70ng/dl). WHO performance status 0-1. Pain that is mild enough (a score of 0, 1 or 2 in the worst pain item of the BPI) to be adequately controlled by non-opiate pain medication.
The pt can be taking opiates for pain clearly not related to prostate cancer. Life expectancy over 6 months
Objectives: To determine the effect of ZD4054 on overall survival, defined as time to death (from randomisation) from any cause, compared to placebo
Status: Follow Up
Chair: Dr. Ho Wing Ming

Renal

(REN001) Phase 3b, Randomized, Open-Label Study of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa as First-line Treatment in Subjects With Advanced Renal Cell Carcinoma

Eligibility: Age >=18 years. Histological and/or cytologic confirmation of Stage IV or recurrent RCC (with > 50% clear-cell component). Bellini tumor or transitional cell carcinoma is NOT allowed. At least 1 measurable lesion per RECIST. Karnofsky performance status >=70%. QTc interval <= 450 msec for males and <= 470 msec for females (site assessment and not independent assessment). Life expectancy at least 12 weeks. Signed and dated IRB/EC approved ICF.
Objectives: The primary objective of this study is a comparison of independently assessed progression free survival (PFS) of subjects with clear cell type renal cell carcinoma treated with of Bevacizumab + Temsirolimus (Experimental arm) versus Bevacizumab + Interferon-Alfa in Subjects With Advanced Renal Cell Carcinoma
Status: Active
Chair: Dr. Ho Wing Ming