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NCT00054561 · ClinicalTrials.gov registry record · Phase 3
Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase 3 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00054561 is a Phase 3 study that has completed, run by Eastern Cooperative Oncology Group.
The verdict
NCT00054561, a Phase 3 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.
Interventions
- PROCEDURE adjuvant therapy
- BIOLOGICAL recombinant interferon alfa
- DIETARY_SUPPLEMENT vitamin E
- DRUG isotretinoin
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-11-26 |
| Est. Completion | 2009-05-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00054561
The ClinicalTrials.gov registry entry for NCT00054561 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which adjuvant therapy is the first listed.
NCT00054561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00054561 about?
NCT00054561 is a clinical study titled "Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer". RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whethe...
What is the current status of trial NCT00054561?
This trial is currently completed. It is a Phase 3 study. The study started on 2003-11-26. Estimated completion is 2009-05-01.
What interventions are being tested in trial NCT00054561?
The interventions under investigation include: adjuvant therapy (PROCEDURE), recombinant interferon alfa (BIOLOGICAL), vitamin E (DIETARY_SUPPLEMENT), isotretinoin (DRUG).
Who is sponsoring clinical trial NCT00054561?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
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