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NCT00084318 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 238
- Enrollment target
NCT00084318 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 238 participants.
The verdict
NCT00084318, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 238 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
Interventions
- DRUG cisplatin
- DRUG docetaxel
- BIOLOGICAL cetuximab
- RADIATION radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2004-04 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00084318
The ClinicalTrials.gov registry entry for NCT00084318 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00084318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00084318 about?
NCT00084318 is a clinical study titled "Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck". RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop ...
What is the current status of trial NCT00084318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 238 participants. The study started on 2004-04. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00084318?
The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), cetuximab (BIOLOGICAL), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00084318?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
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