Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N00CA NCI-P02-0221, N00CA, NCT00033605

Objectives

1. Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea in patients receiving external-beam radiotherapy to the pelvis.
2. Determine the effectiveness of this drug in reducing chronic treatment-related bowel dysfunction in these patients.
3. Determine the toxicity of this drug in these patients.
4. Assess the importance that these patients attach to various measures of bowel function.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• No other concurrent octreotide

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

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

Expected Enrollment

A minimum of 125 patients (62 per treatment arm) will be accrued for this study within 38 months.

Outcomes

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

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

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.

Martenson JA, Halyard MY, Sloan JA, et al.: 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 26 (32): 5248-53, 2008.[PUBMED Abstract]

Martenson JA, Sloan JA, Deming RL, et al.: Phase III double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea during pelvic radiation therapy: results of North Central Cancer Treatment Group protocol N00CA. [Abstract] J Clin Oncol 24 (Suppl 18): A-8506, 469s, 2006.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

James Martenson, MD, Protocol chair		Ph: 507-284-2511

Registry Information
Official Title		Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
Trial Start Date		2002-04-29
Trial Completion Date		2006-07-14
Registered in ClinicalTrials.gov		NCT00033605 1
Date Submitted to PDQ		2002-02-22
Information Last Verified		2005-10-14
NCI Grant/Contract Number		CA31946

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00033605