Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033605
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-04-09
Brief Title:
Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2016-07
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 Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis It is not yet known whether octreotide is effective for diarrhea
PURPOSE Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis
PURPOSE Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis
Detailed Description:
OBJECTIVES
Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea in patients receiving external-beam radiotherapy to the pelvis
Determine the effectiveness of this drug in reducing chronic treatment-related bowel dysfunction in these patients
Determine the toxicity of this drug in these patients
Assess the importance that these patients attach to various measures of bowel function
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior anterior resection of the rectum yes vs no total planned cumulative dose of radiotherapy including boost fields 4500-5350 cGy vs 5351-6000 cGy vs more than 6000 cGy use of concurrent fluorouracil none vs bolus vs continuous infusion use of concurrent leucovorin calcium yes vs no use of concurrent cisplatin yes vs no superior border of initial field at or inferior to the L4-5 interspace vs superior to the L4-5 interspace planned intracavitary brachytherapy yes vs no and primary site of disease rectal cancer vs prostate cancer vs gynecological cancer vs other Beginning no later than the fourth day of radiotherapy patients are randomized to one of two treatment arms
Arm I Patients receive short-acting octreotide subcutaneously SC on day 1 and long-acting octreotide intramuscularly IM on days 2 and 29
Arm II Patients receive placebo SC on day 1 and IM on days 2 and 29 In both arms treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea
Patients complete a bowel function questionnaire at baseline weekly during radiotherapy and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy
Patients are followed weekly for 4 weeks and then at 1 and 2 years
Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea in patients receiving external-beam radiotherapy to the pelvis
Determine the effectiveness of this drug in reducing chronic treatment-related bowel dysfunction in these patients
Determine the toxicity of this drug in these patients
Assess the importance that these patients attach to various measures of bowel function
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior anterior resection of the rectum yes vs no total planned cumulative dose of radiotherapy including boost fields 4500-5350 cGy vs 5351-6000 cGy vs more than 6000 cGy use of concurrent fluorouracil none vs bolus vs continuous infusion use of concurrent leucovorin calcium yes vs no use of concurrent cisplatin yes vs no superior border of initial field at or inferior to the L4-5 interspace vs superior to the L4-5 interspace planned intracavitary brachytherapy yes vs no and primary site of disease rectal cancer vs prostate cancer vs gynecological cancer vs other Beginning no later than the fourth day of radiotherapy patients are randomized to one of two treatment arms
Arm I Patients receive short-acting octreotide subcutaneously SC on day 1 and long-acting octreotide intramuscularly IM on days 2 and 29
Arm II Patients receive placebo SC on day 1 and IM on days 2 and 29 In both arms treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea
Patients complete a bowel function questionnaire at baseline weekly during radiotherapy and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy
Patients are followed weekly for 4 weeks and then at 1 and 2 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-P02-0221 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069304 | REGISTRY | None | None |