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OpenTrials
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NCT Number: NCT00232453

Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven adenocarcinoma of the rectum
  • Performance status <2 (ECOG, appendix II)
  • Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis

Exclusion criteria

  • Prior pelvic irradiation
  • Inflammatory bowel disease
  • Evidence of distant metastasis
  • Performance status >2

Treatment and study plan

Combined Radiation and Chemotherapy

Procedure

Primary outcomes

  1. Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Oct 4, 2005
Registry last updated
Feb 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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