Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
18 Years
N/A
Both
Cervical Cancer, Colorectal Cancer, Diarrhea, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Prostate Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific, Vaginal Cancer, Vulvar Cancer
Trial Information
Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
OBJECTIVES:
- Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea
in patients receiving external-beam radiotherapy to the pelvis.
- Determine the effectiveness of this drug in reducing chronic treatment-related bowel
dysfunction in these patients.
- Determine the toxicity of this drug in these patients.
- Assess the importance that these patients attach to various measures of bowel function.
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.
PROJECTED ACCRUAL: A minimum of 125 patients (62 per treatment arm) will be accrued for this
study within 38 months.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy
Principal Investigator
James A. Martenson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069304
NCT ID:
NCT00033605
Start Date:
April 2002
Completion Date:
Related Keywords:
- Cervical Cancer
- Colorectal Cancer
- Diarrhea
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Prostate Cancer
- Sarcoma
- Unspecified Adult Solid Tumor, Protocol Specific
- Vaginal Cancer
- Vulvar Cancer
- diarrhea
- stage I rectal cancer
- stage II rectal cancer
- stage III rectal cancer
- stage IV rectal cancer
- stage III cervical cancer
- stage IB cervical cancer
- stage IIB cervical cancer
- stage IVB cervical cancer
- stage IIA cervical cancer
- stage IVA cervical cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III vulvar cancer
- stage IVB vulvar cancer
- stage 0 vaginal cancer
- stage I vaginal cancer
- stage II vaginal cancer
- stage III vaginal cancer
- stage IVA vaginal cancer
- stage IVB vaginal cancer
- stage I endometrial carcinoma
- stage II endometrial carcinoma
- stage III endometrial carcinoma
- stage IV endometrial carcinoma
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- unspecified adult solid tumor, protocol specific
- stage II ovarian germ cell tumor
- fallopian tube cancer
- stage I uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- stage IV uterine sarcoma
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Colorectal Neoplasms
- Diarrhea
- Ovarian Neoplasms
- Prostatic Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
- Fallopian Tube Neoplasms
- Adenoma
- Sarcoma
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