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


Phase 2
17 Years
N/A
Open (Enrolling)
Both
Rectal Cancer, Neoplasm Metastasis

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety

Principal Investigator

Gwyn Bebb, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

16080

NCT ID:

NCT00122291

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Neoplasm Metastasis
  • preoperative
  • chemotherapy
  • radiation therapy
  • rectal cancer
  • transmural rectal wall invasion
  • nodal metastasis
  • Neoplasms
  • Rectal Neoplasms
  • Neoplasm Metastasis

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