Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008398
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2001-01-06
Brief Title:
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
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 Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of sargramostim GM-CSF in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy
Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to concurrent cisplatin chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy once daily five days a week for 6-7 weeks Patients also receive sargramostim GM-CSF subcutaneously SC three times a week except on days if receiving concurrent cisplatin beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks
Arm II Patients receive radiotherapy as in arm I Patients also receive placebo SC on the same schedule as GM-CSF in arm I
Quality of life is assessed at baseline and then at 3 6 and 12 months
Patients are followed at 3 6 and 11 months
PROJECTED ACCRUAL A total of 126 patients 63 per arm will be accrued within 12-14 years
Determine the efficacy of sargramostim GM-CSF in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy
Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to concurrent cisplatin chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive radiotherapy once daily five days a week for 6-7 weeks Patients also receive sargramostim GM-CSF subcutaneously SC three times a week except on days if receiving concurrent cisplatin beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks
Arm II Patients receive radiotherapy as in arm I Patients also receive placebo SC on the same schedule as GM-CSF in arm I
Quality of life is assessed at baseline and then at 3 6 and 12 months
Patients are followed at 3 6 and 11 months
PROJECTED ACCRUAL A total of 126 patients 63 per arm will be accrued within 12-14 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-P00-0177 | None | None | None |
| CDR0000068406 | None | None | None |