Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Brief Summary: RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.


Options:
A: Inclusion Criteria:

* female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

* previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre
B: Inclusion Criteria:

* Histologically proven prostate cancer.
* Surgical candidate for prostatectomy.
* During study period, must agree not to take new supplements.
* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
* Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
C: DISEASE CHARACTERISTICS:

* Diagnosis of cancer that supports the use of radiotherapy to the pelvis
* No current or prior metastases beyond pelvic regional lymph nodes
* Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin
* Planned course of pelvic radiotherapy must fall within the following parameters:

  * Pelvis must be encompassed by the planned radiotherapy fields

    * Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
    * Portions of the rectum may have special blocking, depending upon disease site
  * Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)\*

    * Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned
  * Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

    * Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day\*
* NOTE: \*For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
* No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
* No brachytherapy planned before the completion of all external-beam radiotherapy
* No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 10.0 g/dL
* Leukocytes ≥ 3,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
* Able to complete questionnaires alone or with assistance
* No history of inflammatory bowel disease
* No history of gastrointestinal or genitourinary obstruction or porphyria
* No history of G6PD deficiency
* No history of irritable bowel syndrome
* No history of blood dyscrasia
* No history of severe allergies or asthma
* No history of hepatic or renal disease
* No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
* No medical condition that may interfere with the ability to receive study treatment
* No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic radiotherapy
* No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
* No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
* No other concurrent sulfasalazine
* No concurrent digoxin
D: 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

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:

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

Answer: C