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Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

Primary Purpose

Cervical Cancer, Colorectal Cancer, Diarrhea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
octreotide acetate
placebo
radiation
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed cancer in the pelvis Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy) Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints) Portions of rectum may have special blocking depending on disease site Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy) No planned split-course radiotherapy No planned interstitial brachytherapy prior to completion of external-beam radiotherapy Planned intracavitary radiotherapy allowed No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin Entered on study before the third radiotherapy fraction No current or prior metastases beyond pelvic or para-aortic lymph nodes No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy No incontinence of stool PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Renal: No chronic renal failure Creatinine less than 2 times upper limit of normal (for patients with history of renal disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known allergy to octreotide No history of inflammatory bowel disease No other concurrent medical condition that would preclude study participation No history of cholecystitis unless prior cholecystectomy PRIOR CONCURRENT THERAPY: Radiotherapy: See Disease Characteristics No prior radiotherapy to the pelvis Surgery: See Disease Characteristics No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    octreotide + radiation

    placebo + radiation

    Arm Description

    Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29. 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.

    Patients receive placebo SC on day 1 and IM on days 2 and 29. 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.

    Outcomes

    Primary Outcome Measures

    Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy

    Secondary Outcome Measures

    Reduction of patient-reported bowel dysfunction as assessed by the bowel function questionnaire weekly during radiotherapy, weekly for 4 weeks after radiotherapy, and 12 and 24 months after completion of radiotherapy
    Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy
    Importance that patients attach to various measures of bowel dysfunction as assessed by questionnaire at week 4 of radiotherapy and at 12 and 24 months after completion of radiotherapy

    Full Information

    First Posted
    April 9, 2002
    Last Updated
    July 12, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00033605
    Brief Title
    Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
    Official Title
    Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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 (4,500-5,350 cGy vs 5,351-6,000 cGy vs more than 6,000 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Colorectal Cancer, Diarrhea, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Prostate Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific, Vaginal Cancer, Vulvar Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    octreotide + radiation
    Arm Type
    Experimental
    Arm Description
    Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29. 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.
    Arm Title
    placebo + radiation
    Arm Type
    Active Comparator
    Arm Description
    Patients receive placebo SC on day 1 and IM on days 2 and 29. 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.
    Intervention Type
    Drug
    Intervention Name(s)
    octreotide acetate
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation
    Primary Outcome Measure Information:
    Title
    Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Reduction of patient-reported bowel dysfunction as assessed by the bowel function questionnaire weekly during radiotherapy, weekly for 4 weeks after radiotherapy, and 12 and 24 months after completion of radiotherapy
    Time Frame
    Up to 2 years
    Title
    Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy
    Time Frame
    Up to 2 years
    Title
    Importance that patients attach to various measures of bowel dysfunction as assessed by questionnaire at week 4 of radiotherapy and at 12 and 24 months after completion of radiotherapy
    Time Frame
    Up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed cancer in the pelvis Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy) Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints) Portions of rectum may have special blocking depending on disease site Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy) No planned split-course radiotherapy No planned interstitial brachytherapy prior to completion of external-beam radiotherapy Planned intracavitary radiotherapy allowed No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin Entered on study before the third radiotherapy fraction No current or prior metastases beyond pelvic or para-aortic lymph nodes No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy No incontinence of stool PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Renal: No chronic renal failure Creatinine less than 2 times upper limit of normal (for patients with history of renal disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known allergy to octreotide No history of inflammatory bowel disease No other concurrent medical condition that would preclude study participation No history of cholecystitis unless prior cholecystectomy PRIOR CONCURRENT THERAPY: Radiotherapy: See Disease Characteristics No prior radiotherapy to the pelvis Surgery: See Disease Characteristics No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James A. Martenson, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18768432
    Citation
    Martenson JA, Halyard MY, Sloan JA, Proulx GM, Miller RC, Deming RL, Dick SJ, Johnson HA, Tai TH, Zhu AW, Keit J, Stien KJ, Atherton PJ. Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA. J Clin Oncol. 2008 Nov 10;26(32):5248-53. doi: 10.1200/JCO.2008.17.1546. Epub 2008 Sep 2.
    Results Reference
    result

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    Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

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