Study of brachytherapy in rectal cancer

Phase 2

• Conditions: Rectal cancer.; Rectal and anal canal neoplasms; C20, C21.1

• Registration Number: IRCT201501059979N2
• Lead Sponsor: Vice chancellor for research,, Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:
•Pathologically proved adenocarcinoma of the rectum
•Age 18 or older
•Clinically staged II-III tumor by MRI and/or EUS
•ECOG performance status of 0 or 1
•Tumors located at up to10 cm of the anus
•No previous history of malignancy, pelvic radiotherapy or chemotherapy
•Normal or adequate bone marrow reserve
•Normal or adequate liver and kidney function
•

Exclusion Criteria

•Patients with tumors >12 cm from the anal verge.
•Near obstructing or bulky tumors which will not allow application of the endorectal applicator before or after chemoradiation
•Patients with distant metastatic disease
•Prior history of radiation therapy to the pelvis
•Prior history of chemotherapy for rectal cancer
•Active connective tissue disease such as scleroderma or Crohn's disease
•Uncontrolled diabetes mellitus, hypertension or recent cardiovascular disease
•Significant neuropathy
• Any previous or recent hypersensitivity or contraindication for chemotherapy agents

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response. Timepoint: Before intervention and After surgical resection. Method of measurement: Pathologic examination.;Treatment-related side effects. Timepoint: Weekly measurement from the first week to the end of intervention. Method of measurement: According to the Common Terminology Criteria for Adverse Events (version 4.0).