- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997906
Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC
A Randomised Phase II/III Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy my kill more tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with nasopharyngeal cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together with radiation therapy works compared with giving cisplatin and radiation therapy together with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally advanced nasopharyngeal cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- To compare the 5-year overall survival of patients with locally advanced nasopharyngeal cancer treated with concurrent cisplatin and radiotherapy with vs without induction chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.
Secondary
- To assess and compare the disease-free survival, distant metastases rate, toxicities, and quality of life of patients treated with these regimens.
OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
- Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169610
- National Cancer Centre - Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Patients are eligible for inclusion if all of the following criteria are fulfilled:
- Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice.
- Loco-regional advanced NPC UICC (1997) Stages T3 - 4 any N, or any Stage T, N2 - 3.
- A histological diagnosis of WHO Type II or III NPC must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization.
- No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
- Cross sectional imaging of the primary and neck disease (MRI preferred)
- Evaluable disease must be present.
- Performance status of ECOG grade 0 or 1 (see Appendix I).
- No prior tumour therapy
Adequate bone marrow, renal and hepatic function:
Bone marrow : WBC > 3000 / mm3 (ANC > 1500 / mm3 ),
- Platelets > 100 000 / mm3,
- Hb > 10 gm/dl Renal : serum creatinine within institutional normal range (or) lower than the lower limit of institutional normal range
- calculated creatinine clearance > 50 ml / min Hepatic : enzymes (SAP, SGOT) < 2x normal
- bilirubin < 24 µmol / l.
- At least 18 years of age, of either sex.
Exclusion criteria:
Patients are to be excluded from the study if any of the following criteria is fulfilled:
- Uncontrolled hypercalcaemia: calcium ≥ 2.7 mmol/L (10.8 mg/dL).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
- Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Have serious active infection.
- Hepatitis B carrier
- Prior treatment including chemotherapy or radiotherapy.
- Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
|
Given IV
Given once daily 5 days a week for 6½ weeks.
|
Experimental: Arm II
Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses.
Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.
|
Given IV
Given IV
Given IV
Given once daily 5 days a week for 6½ weeks.
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival at 5 years
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival
Time Frame: 10 years
|
10 years
|
Metastases-free survival
Time Frame: 10 years
|
10 years
|
Tumor recurrence
Time Frame: 10 years
|
10 years
|
Toxicity according to the Common Toxicity Criteria
Time Frame: 10 years
|
10 years
|
Quality of life as measured by the EORTC QLQ-C30
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Terence Tan, FRCR, National Cancer Centre, Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- CDR0000657121
- SINGAPORE-NCC0901 (Other Identifier: National Cancer Centre Singapore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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