Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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| ClinicalTrials.gov Identifier: NCT00075868 |
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Recruitment Status :
Completed
First Posted : January 13, 2004
Last Update Posted : November 17, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anal Cancer Colorectal Cancer Drug/Agent Toxicity by Tissue/Organ Radiation Enteritis | Drug: octreotide acetate Other: Placebo | Phase 3 |
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 (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
- Compare treatment delays and/or 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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 233 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Supportive Care |
| 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 |
| Study Start Date : | December 2003 |
| Actual Primary Completion Date : | August 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sandostatin LAR® Depot
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
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Drug: octreotide acetate |
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Placebo Comparator: Placebo
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
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Other: Placebo |
- Prevention of the incidence of moderate, severe, or life-threatening diarrhea
- Quality of life
- Economic measures
- 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
- Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075868
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| Principal Investigator: | Babu Zachariah, MD | H. Lee Moffitt Cancer Center and Research Institute | |
| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
Publications of Results:
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00075868 History of Changes |
| Other Study ID Numbers: |
RTOG-0315 CDR0000349441 |
| First Posted: | January 13, 2004 Key Record Dates |
| Last Update Posted: | November 17, 2015 |
| Last Verified: | November 2015 |
Keywords provided by Radiation Therapy Oncology Group:
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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 |
Additional relevant MeSH terms:
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Colorectal Neoplasms Rectal Neoplasms Diarrhea Anus Neoplasms Enteritis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive Signs and Symptoms Anus Diseases Gastroenteritis Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |