Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006481
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-11-06
Brief Title:
Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-11
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 Radiation therapy uses high-energy x-rays to damage tumor cells but may cause skin irritation and inflammation Biafine cream may be effective in lessening side effects caused by radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of Biafine cream in reducing side effects of radiation therapy in patients receiving treatment for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of Biafine cream in reducing side effects of radiation therapy in patients receiving treatment for head and neck cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of prophylactic Biafine cream vs standard best supportive care in reducing grade 2 or higher radiation-induced skin toxicity observed during radiotherapy in patients with advanced squamous cell carcinoma of the head and neck II Determine if prophylactic or interventional use of Biafine cream is more effective based on a reduction in maximum skin toxicity resulting from radiation treatment in this patient population III Compare quality of life of these patients with this treatment IV Assess the toxicity of Biafine cream in these patients
OUTLINE This is a randomized study Patients are stratified according to lymph node status negative vs positive type of treatment radiation plus chemotherapy vs radiation alone radiation fractionation standard vs concurrent boost and radiation dose 50-60 Gy vs greater than 60 Gy Patients are randomized to 1 of 3 treatment arms Arm I Patients receive radiotherapy once daily 5 days a week for 5-8 weeks with or without standard skin cream application no Biafine cream to irradiated skin Arm II Patients receive radiotherapy as in arm I with Biafine cream applied to skin 3 times daily 7 days a week at the initiation of radiotherapy and continuing for 2 weeks after the last radiation treatment Biafine cream is applied no fewer than 4 hours before treatment and no fewer than 4 hours between applications Arm III Patients receive radiotherapy as in arms I and II with Biafine cream applied as in arm II only after skin becomes symptomatic ie redness dryness itching or tenderness Quality of life is assessed before treatment weekly during treatment and then weekly for 4 weeks after treatment completion Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study within 17 months
OUTLINE This is a randomized study Patients are stratified according to lymph node status negative vs positive type of treatment radiation plus chemotherapy vs radiation alone radiation fractionation standard vs concurrent boost and radiation dose 50-60 Gy vs greater than 60 Gy Patients are randomized to 1 of 3 treatment arms Arm I Patients receive radiotherapy once daily 5 days a week for 5-8 weeks with or without standard skin cream application no Biafine cream to irradiated skin Arm II Patients receive radiotherapy as in arm I with Biafine cream applied to skin 3 times daily 7 days a week at the initiation of radiotherapy and continuing for 2 weeks after the last radiation treatment Biafine cream is applied no fewer than 4 hours before treatment and no fewer than 4 hours between applications Arm III Patients receive radiotherapy as in arms I and II with Biafine cream applied as in arm II only after skin becomes symptomatic ie redness dryness itching or tenderness Quality of life is assessed before treatment weekly during treatment and then weekly for 4 weeks after treatment completion Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study within 17 months
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 |
|---|---|---|---|
| CDR0000068312 | None | None | None |
| NCI-P00-0173 | None | None | None |