Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-07 @ 12:06 AM
Study NCT ID:
NCT00075868
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2004-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-14', 'studyFirstSubmitDate': '2004-01-09', 'studyFirstSubmitQcDate': '2004-01-12', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of the incidence of moderate, severe, or life-threatening diarrhea'}], 'secondaryOutcomes': [{'measure': 'Quality of life'}, {'measure': 'Economic measures'}, {'measure': 'Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires'}, {'measure': 'Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiation enteritis', 'drug/agent toxicity by tissue/organ', 'stage I rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer', 'stage IIIA anal cancer', 'stage IIIB anal cancer', 'recurrent anal cancer', 'stage I anal cancer', 'stage II anal cancer', 'recurrent rectal cancer'], 'conditions': ['Anal Cancer', 'Colorectal Cancer', 'Drug/Agent Toxicity by Tissue/Organ', 'Radiation Enteritis']}, 'referencesModule': {'references': [{'pmid': '20339140', 'type': 'RESULT', 'citation': 'Zachariah B, Gwede CK, James J, Ajani J, Chin LJ, Donath D, Rosenthal SA, Kane BL, Rotman M, Berk L, Kachnic LA. Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial 0315. J Natl Cancer Inst. 2010 Apr 21;102(8):547-56. doi: 10.1093/jnci/djq063. Epub 2010 Mar 25.'}, {'type': 'RESULT', 'citation': 'Zachariah B, James J, Gwede CK, et al.: RTOG 0315: a randomized, double-blind, placebo-controlled phase III study to determine the efficacy of octreotide acetate in preventing or reducing the severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-4032, 2007.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Compare the quality of life of patients treated with this drug vs placebo.\n* Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.\n* Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.\n\nOUTLINE: 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.\n\n* Arm I: Patients receive octreotide\\* intramuscularly (IM) 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.\n* Arm II: Patients receive placebo\\* IM 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.\n\nNOTE: \\*Patients receive a total of 2 injections of octreotide or placebo\n\nIn both arms, treatment continues in the absence of unacceptable toxicity.\n\nQuality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6, 9, and 15 months from the start of chemoradiotherapy.\n\nPatients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.\n\nPROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary anal or rectal cancer\n\n * No metastasis beyond the pelvic regional nodes\n* Must be scheduled to receive chemoradiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Liver function tests \\< 3 times upper limit of normal\n* No prior hepatic disease\n\nRenal\n\n* Not specified\n\nGastrointestinal\n\n* No prior chronic or acute regional enteritis\n* No malabsorption syndrome\n* No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity\n* No grade 2 or greater uncontrollable diarrhea at baseline\n* No prior cholecystitis or gallstones, unless a cholecystectomy has been performed\n* No prior incontinence of stool\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No uncontrolled diabetes (e.g., fasting glucose \\> 250 mg/dL)\n* No prior allergy or hypersensitivity to study drug or other related drug or compound\n* No other medical condition or mental impairment that would preclude study treatment and compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* Prior chemotherapy allowed\n\nEndocrine therapy\n\n* At least 6 months since prior administration of any of the following:\n\n * Glucocorticoid therapy\n * Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)\n * Exogenous growth hormone therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior pelvic radiotherapy\n* No prior intensity-modulated radiotherapy\n* No concurrent radiotherapy for abdominal cancer\n* No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy\n* No brachytherapy prior to or after completion of all external beam radiotherapy\n\nSurgery\n\n* No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum\n* No colostomy\n\nOther\n\n* More than 30 days since other prior investigational drugs\n* No prior octreotide for cancer therapy-related diarrhea\n* No concurrent prophylactic antidiarrheal medication'}, 'identificationModule': {'nctId': 'NCT00075868', 'briefTitle': 'Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RTOG-0315'}, 'secondaryIdInfos': [{'id': 'CDR0000349441'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sandostatin LAR® Depot', 'description': 'Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)', 'interventionNames': ['Drug: octreotide acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'octreotide acetate', 'type': 'DRUG', 'armGroupLabels': ['Sandostatin LAR® Depot']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foundation for Cancer Research and Education', 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Memorial Hospital', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '91328', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Leavey Cancer Center at Northridge Hospital Medical Center', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'CCOP - Bay Area Tumor Institute', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Pomona Valley Hospital Medical Center', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento Medical Group, Incorporated', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of 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'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist-South Miami Regional Cancer Program', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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