Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT00423930
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICAL
- cisplatin — DRUG
- conventional surgery — PROCEDURE
- intensity-modulated radiation therapy — RADIATION
Study Details
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.
Key Dates
- First listed
- Jan 18, 2007
- Start date
- Oct 31, 2006
- Status verified
- Jul 2017
- Primary completion
- Jul 31, 2016
- Completion
- Jul 31, 2016
Study Design
- Enrollment
- 44 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: IMRT + cisplatin + bevacizumabThis is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
Primary Outcome Measure
Progression-free Survival at 2 Years [ Time Frame: Percentage of Participants Experiencing Progression-free Survival at 2 Years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | - |
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