Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer - Full Text View

Purpose

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	Intervention	Phase
Anal Cancer Colorectal Cancer Drug/Agent Toxicity by Tissue/Organ Radiation Enteritis	Drug: octreotide acetate Other: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Anal Cancer Cancer Diarrhea

Drug Information available for: Octreotide acetate Octreotide

Genetic and Rare Diseases Information Center resources: Anal Cancer Rectal Neoplasm

U.S. FDA Resources

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome Measures:

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


Enrollment:	233
Study Start Date:	December 2003
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sandostatin LAR® Depot Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)	Drug: octreotide acetate
Placebo Comparator: Placebo Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)	Other: Placebo

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 (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.

Eligibility


Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075868

Show 112 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Babu Zachariah, MD	H. Lee Moffitt Cancer Center and Research Institute
Study Chair:	Jaffer A. Ajani, MD	M.D. Anderson Cancer Center

More Information

Publications:

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.

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.


Responsible Party:	Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00075868 History of Changes
Other Study ID Numbers:	RTOG-0315 CDR0000349441
Study First Received:	January 9, 2004
Last Updated:	November 14, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:


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:


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

ClinicalTrials.gov processed this record on September 26, 2016