Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00084318 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 238 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessar
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 |
What the finished NCT00084318 record still lists
NCT00084318 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00084318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00084318's enrollment target sits among peer trials
238 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05012072 · 238 participants · NA
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
- NCT05400252 · 238 participants · NA
Whole Health in VA Mental Health: Omnis Salutis
- NCT06380517 · 238 participants · Phase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
- NCT06452797 · 238 participants · NA
Prognostic Estimates Among ICU Clinicians
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia