A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

Overview

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Full Title of Study: “A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Interventions

  • Drug: Capecitabine
  • Procedure: Pelvic radiation

Clinical Trial Outcome Measures

Primary Measures

  • safety
  • response

Participating in This Clinical Trial

Inclusion Criteria

  • Biopsy – proven rectal cancer – Transmural rectal wall invasion – Karnofsky performance status >70 – Normal bone marrow, liver and kidney function Exclusion Criteria:

  • Distant metastases – Prior pelvic radiation – Inflammatory bowel disease – Severe ischemic heart disease – Anticoagulant therapy – Pregnancy

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alberta Health services
  • Overall Official(s)
    • Gwyn Bebb, MD, Principal Investigator, Alberta Health services

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