Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT00075868
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00075868
Study Brief:
Protocol Section:
NCT00075868