Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002932
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
1999-11-01
Brief Title:
Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2014-11
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 Drugs used in chemotherapy use 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 Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck
PURPOSE Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck
Detailed Description:
OBJECTIVES I Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck II Determine the partial and complete response rate of cisplatin chemoradiation III Determine the incidence of adverse events using cisplatin chemoradiation therapy IV Determine the rate of disease-free survival and overall survival in these patients V Determine the incidence and pattern of recurrence in these patients VI Document quality of life measured by disease-specific instruments in these patients
OUTLINE All patients receive four courses of cisplatin on days 1 8 15 and 22 concurrent with radiotherapy One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes Radiotherapy is given 5 days a week for 7 weeks This weekly cisplatin chemoradiation course will be repeated 4 times providing recovery from toxicity is present Dexamethasone is started the evening prior to cisplatin treatment and continues until the morning following the procedure
PROJECTED ACCRUAL 60 patients will be enrolled
OUTLINE All patients receive four courses of cisplatin on days 1 8 15 and 22 concurrent with radiotherapy One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes Radiotherapy is given 5 days a week for 7 weeks This weekly cisplatin chemoradiation course will be repeated 4 times providing recovery from toxicity is present Dexamethasone is started the evening prior to cisplatin treatment and continues until the morning following the procedure
PROJECTED ACCRUAL 60 patients will be enrolled
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 |
|---|---|---|---|
| CDR0000065366 | None | None | None |