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Sulfasalazine in Preventing A...

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

NCT ID: NCT01198145

Last Updated: 2020-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-07-15

Brief Summary

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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.

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Detailed Description

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OBJECTIVES:

Primary

* To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

* To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.
* To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

* To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs \> 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy.
* Arm II: Patients receive oral placebo twice daily during radiotherapy\* and for 4 weeks after completion of radiotherapy.

NOTE: \*Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.

Conditions

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Diarrhea Gastrointestinal Complications Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I: Sulfasalazine

Patients receive oral sulfasalazine twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Group Type EXPERIMENTAL

sulfasalazine

Intervention Type DRUG

Given orally

Arm II: Placebo

Patients receive oral placebo twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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sulfasalazine

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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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\*
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C. Miller, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status