Trial record 1 of 179 for:    N08C9
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Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01198145
First received: September 8, 2010
Last updated: August 6, 2013
Last verified: February 2013

September 8, 2010
August 6, 2013
April 2011
June 2015   (final data collection date for primary outcome measure)
Maximum severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after radiotherapy (RT) [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]
Maximum severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after radiotherapy (RT) [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01198145 on ClinicalTrials.gov Archive Site
  • Maximum severity and the duration of maximum severity of each outcome variable (i.e., rectal bleeding, abdominal cramping, tenesmus, constipation, and diarrhea) measured during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]
  • Area under the curve that combines the individual severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: Yes ]
  • Average score for each outcome variable [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience each outcome variable during and after RT [ Time Frame: Up to 6 weeks post radiation therapy ] [ Designated as safety issue: No ]
  • Long-term diarrhea severity grade [ Time Frame: Up to 24 months post radiation therapy ] [ Designated as safety issue: No ]
  • Long-term bowel function score [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percent of patients in each arm that recorded "yes" to each of questions 2-12 on the bowel function questionnaire [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that require any and each type of antidiarrheal medications [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience clinically significant deficits in overall quality of life and fatigue [ Time Frame: Up to 24 months post radiotherapy ] [ Designated as safety issue: No ]
  • Maximum severity and the duration of maximum severity of each outcome variable (i.e., rectal bleeding, abdominal cramping, tenesmus, constipation, and diarrhea) measured during and after RT [ Designated as safety issue: Yes ]
  • Area under the curve that combines the individual severity of diarrhea toxicity as measured by the CTCAE v4.0 during and after RT [ Designated as safety issue: No ]
  • Average score for each outcome variable during RT [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience each outcome variable during and after RT [ Designated as safety issue: No ]
  • Long-term diarrhea severity grade [ Designated as safety issue: No ]
  • Long-term bowel function score [ Designated as safety issue: No ]
  • Percent of patients in each arm that recorded "yes" to each of questions 2-12 on the bowel function questionnaire [ Designated as safety issue: No ]
  • Percentage of patients in each arm that require any and each type of antidiarrheal medications [ Designated as safety issue: No ]
  • Percentage of patients in each arm that experience clinically significant deficits in overall quality of life and fatigue [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Diarrhea
  • Gastrointestinal Complications
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: sulfasalazine
    Given orally
  • Other: placebo
    Given orally
  • Experimental: Arm I
    Patients receive oral sulfasalazine twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
    Intervention: Drug: sulfasalazine
  • Placebo Comparator: Arm II
    Patients receive oral placebo twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01198145
NCCTG-N08C9, NCI-2011-02602, CDR0000684240
Yes
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Robert C. Miller, MD Mayo Clinic
Study Chair: Daniel A. Petereit, MD Rapid City Regional Hospital
Alliance for Clinical Trials in Oncology
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP