Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004256
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2000-01-28
Brief Title:
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
Status:
COMPLETED
Status Verified Date:
2006-08
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 such as sargramostim may protect normal cells from the side effects of radiation therapy
PURPOSE Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer
PURPOSE Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of sargramostim GM-CSF in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma
Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status analgesic use and days in the hospital
OUTLINE This is a randomized study
Patients receive radiotherapy in 16 fractions over 21 days Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins
Arm I Patients receive sargramostim GM-CSF SC daily for 14 days beginning on day 14 of the course of radiotherapy
Arm II Patients do not receive GM-CSF Patients are followed weekly until mucositis is healed as well as at weeks 2 and 6 following the end of radiotherapy
PROJECTED ACCRUAL A total of 34 patients 17 per arm will be accrued for this study
Determine the efficacy of sargramostim GM-CSF in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma
Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status analgesic use and days in the hospital
OUTLINE This is a randomized study
Patients receive radiotherapy in 16 fractions over 21 days Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins
Arm I Patients receive sargramostim GM-CSF SC daily for 14 days beginning on day 14 of the course of radiotherapy
Arm II Patients do not receive GM-CSF Patients are followed weekly until mucositis is healed as well as at weeks 2 and 6 following the end of radiotherapy
PROJECTED ACCRUAL A total of 34 patients 17 per arm will be accrued for this study
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 |
|---|---|---|---|
| EU-99041 | None | None | None |
| RMNHS-GMCSF | None | None | None |