Effect of preoperative chemotherapy in the treatment of patients with locally advanced rectal cancer

Phase 2

• Conditions: Malignant neoplasm of rectum; Rectal cancer.

• Registration Number: IRCT2016082129403N2
• 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: 40

Inclusion Criteria

pathologically proved adenocarcinoma of the rectum; age 18 years old or older; clinically staged II-III tumor by MRI and/or EUS; ECOG performance status of 0 or 1; 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 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.

Exclusion Criteria

Not provided

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.

Secondary Outcome Measures

Name	Time	Method
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).