Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002507
Status:
COMPLETED
Last Update Posted:
2013-07-25
First Post:
1999-11-01
Brief Title:
Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of mitomycin vs porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy Irradiation of involved head and neck sites by external-beam radiotherapy EBRT alone source not specified brachytherapy alone using permanent or removable radiation sources or both plus Mitomycin MITO NSC-26980 Arm II Radiotherapy plus Single-Agent Chemotherapy Radiotherapy as in Arm I plus Porfiromycin NSC-56410
PROJECTED ACCRUAL Approximately 200 patients will be entered over 3-4 years
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy Irradiation of involved head and neck sites by external-beam radiotherapy EBRT alone source not specified brachytherapy alone using permanent or removable radiation sources or both plus Mitomycin MITO NSC-26980 Arm II Radiotherapy plus Single-Agent Chemotherapy Radiotherapy as in Arm I plus Porfiromycin NSC-56410
PROJECTED ACCRUAL Approximately 200 patients will be entered over 3-4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V92-0190 | None | None | None |
| YALE-HIC-6611 | None | None | None |