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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Bladder, Uterine Cervix, Prostate, Ovarian, and Colorectal

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

Unique Dataset IDnci-data-374ClinicalTrial.gov IDNCT01198145
DownloadableNo
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients87RandomizationYesPubMed (PMID)27354129.0
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypeRadiation, DrugDataset TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See Data Dictionary.

Study 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).

Outcome Measures

Primary: Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) [ Time Frame: During radiation therapy and up to 6 weeks post radiation therapy ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

Dataset NCT01198145-D2 (supplemental) is one of 2 datasets associated with PubMed ID 27354129. This dataset contains information that will allow you to reproduce supplemental table 1. All Adverse events reported were collected and graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Available Downloads: NCT01198145-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01198145-D2-Data-Dictionary_3.pdf

DATA: NCT01198145-D2-Dataset_2.csv

OTHER: README.pdf

Available Downloads: NCT01198145-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01198145-D1-Data-Dictionary_2.pdf

DATA: NCT01198145-D1-Dataset.csv

OTHER: README.pdf