Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075868
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2004-01-09
Brief Title:
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR Depot Octreotide Acetate In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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 Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer It is not yet known whether octreotide is effective in treating diarrhea
PURPOSE This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer
PURPOSE This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the ability of octreotide to prevent the incidence of moderate severe or life-threatening chemoradiotherapy-induced diarrhea grades 2-4 in patients with anal or rectal cancer
Secondary
Compare the quality of life of patients treated with this drug vs placebo
Compare the number of hospitalizations and use of antidiarrheal agents eg Imodium related to diarrhea or its complications in patients treated with these drugs
Compare treatment delays andor dose reductions chemotherapy and radiotherapy in patients treated with these drugs
OUTLINE This is a double-blind placebo-controlled randomized multicenter study Patients are stratified according to radiotherapy dose 50 Gy vs 50 Gy chemotherapy dose bolus vs continuous and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive octreotide intramuscularly IM 4-7 days before the start of chemoradiotherapy and on day 22 3 days during chemoradiotherapy
Arm II Patients receive placebo IM 4-7 days before the start of chemoradiotherapy and on day 22 3 days during chemoradiotherapy
NOTE Patients receive a total of 2 injections of octreotide or placebo
In both arms treatment continues in the absence of unacceptable toxicity
Quality of life is assessed at baseline at the completion of chemoradiotherapy and at 3 6 9 and 15 months from the start of chemoradiotherapy
Patients are followed at 3 6 9 and 15 months from the start of chemoradiotherapy
PROJECTED ACCRUAL A total of 226 patients 113 per treatment arm will be accrued for this study within 2 years
Primary
Determine the ability of octreotide to prevent the incidence of moderate severe or life-threatening chemoradiotherapy-induced diarrhea grades 2-4 in patients with anal or rectal cancer
Secondary
Compare the quality of life of patients treated with this drug vs placebo
Compare the number of hospitalizations and use of antidiarrheal agents eg Imodium related to diarrhea or its complications in patients treated with these drugs
Compare treatment delays andor dose reductions chemotherapy and radiotherapy in patients treated with these drugs
OUTLINE This is a double-blind placebo-controlled randomized multicenter study Patients are stratified according to radiotherapy dose 50 Gy vs 50 Gy chemotherapy dose bolus vs continuous and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive octreotide intramuscularly IM 4-7 days before the start of chemoradiotherapy and on day 22 3 days during chemoradiotherapy
Arm II Patients receive placebo IM 4-7 days before the start of chemoradiotherapy and on day 22 3 days during chemoradiotherapy
NOTE Patients receive a total of 2 injections of octreotide or placebo
In both arms treatment continues in the absence of unacceptable toxicity
Quality of life is assessed at baseline at the completion of chemoradiotherapy and at 3 6 9 and 15 months from the start of chemoradiotherapy
Patients are followed at 3 6 9 and 15 months from the start of chemoradiotherapy
PROJECTED ACCRUAL A total of 226 patients 113 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000349441 | None | None | None |