A Study of the Effectiveness of Sulfasalazine in Preventing Acute Diarrhea in Patients with Cancer who are Undergoing Pelvic Radiation Therapy

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 10-002741
    • Scottsdale/Phoenix, Arizona: 10-002741
    NCT ID: NCT01198145
    Sponsor Protocol Number: N08C9

About this study

 

The purpose of this study of sulfasalazine is to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy. Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

The recruitment status of this study is unknown because the information has not been verified recently. Verified February 2013 by Alliance for Clinical Trials in Oncology.
Recruitment status was  Active, not recruiting

Inclusion Criteria

  • 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
        • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Miller, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Miller, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315196

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