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NCT00533949 · ClinicalTrials.gov registry record · Phase 3
High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
NCT00533949: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00533949 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 544 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00533949, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin 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 cetuximab 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. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Primary Outcome
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Interventions
- DRUG Carboplatin
- BIOLOGICAL Cetuximab
- DRUG Paclitaxel
- RADIATION 60 Gy RT
- RADIATION 74 Gy RT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2007-11 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT00533949 record still lists
NCT00533949 is an interventional study that assigns participants to a tested intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT00533949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00533949 about?
NCT00533949 is a clinical study titled "High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin 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 cetuximab can ...
What is the current status of trial NCT00533949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2007-11. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT00533949?
The interventions under investigation include: Carboplatin (DRUG), Cetuximab (BIOLOGICAL), Paclitaxel (DRUG), 60 Gy RT (RADIATION), 74 Gy RT (RADIATION).
Who is sponsoring clinical trial NCT00533949?
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 NCT00533949's enrollment target sits among peer trials
544 691st of 2000 higher than 1,307 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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