Clinical trial · Interventional
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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
NCT00075868CI-TRIAL-00019801completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Radiation Enteritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| octreotide acetate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
- Prevention of the incidence of moderate, severe, or life-threatening diarrhea
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary anal or rectal cancer * No metastasis beyond the pelvic regional nodes * Must be scheduled to receive chemoradiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Liver function tests \< 3 times upper limit of normal * No prior hepatic disease Renal * Not specified Gastrointestinal * No prior chronic or acute regional enteritis * No malabsorption syndrome * No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity * No grade 2 or greater uncontrollable diarrhea at baseline * No prior cholecystitis or gallstones, unless a cholecystectomy has been performed * No prior incontinence of stool Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No uncontrolled diabetes (e.g., fasting glucose \> 250 mg/dL) * No prior allergy or hypersensitivity to study drug or other related drug or compound * No other medical condition or mental impairment that would preclude study treatment and compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior chemotherapy allowed Endocrine therapy * At least 6 months since prior administration of any of the following: * Glucocorticoid therapy * Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone) * Exogenous growth hormone therapy Radiotherapy * See Disease Characteristics * No prior pelvic radiotherapy * No prior intensity-modulated radiotherapy * No concurrent radiotherapy for abdominal cancer * No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy * No brachytherapy prior to or after completion of all external beam radiotherapy Surgery * No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum * No colostomy Other * More than 30 days since other prior investigational drugs * No prior octreotide for cancer therapy-related diarrhea * No concurrent prophylactic antidiarrheal medication
References
Publications (2)
- RESULTZachariah 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. PMID 20339140
- RESULTZachariah 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.