Preoperative Radiotherapy and Local Excision in Rectal Cancer

April 14, 2010 updated by: Polish Colorectal Cancer Study Group

The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer

According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. After 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. Patients with good pathological response (complete response or downstaging to ypT1 disease)are followed up. Conversion to open surgery is offered to patients with poor pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. Rescue surgery is offered in patients with local recurrence.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-781
        • Recruiting
        • M. Sklodowska-Curie Memorial Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy proven good or moderately differentiated adenocarcinoma of rectum
  • Extraperitoneal tumour (< 3-4 cm; unfavourable cT1 or cT2-3; N0)
  • No evidence of distant metastases on chest X-ray and abdominal CT or sonography
  • Signed by patient written informed consent

Exclusion Criteria:

  • Poorly differentiated pathology (G3)
  • Patients unfit for chemotherapy
  • No agreement for randomisation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Preoperative radiotherapy with five fractions of 5 Gy during one week and boost 4 Gy after 1 week interval, total dose 29 Gy; after 6 weeks full-thickness local excision
Radiation: Short course of radiotherapy
5 x 5 Gy plus boost 4 Gy
Other Names:
  • short radiation
Active Comparator: 2

Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions

+ simultaneous bolus 5-Fluorouracil and leucovorin; after 6 weeks full-thickness local excision
Radiation: Radiochemotherapy
28 x 1,8Gy plus boost 3 x 1,8 Gy with three 2-days cycles of chemotherapy during weeks 1, 3 and 5 of irradiation (the each cycle consisted of leukovorin 20 mg/m2 per day and 10-20 minutes later of 5-fluorouracil 400 mg/m2 per day, both administrated as rapid intravenous infusion)
Other Names:
  • chemoradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
Time Frame: Surrogate endpoint available immediatly after surgery.
Surrogate endpoint available immediatly after surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of local control, overall survival and disease-free survival and toxicity.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polish Colorectal Cancer Study Group

Collaborators

Poznan University of Medical Sciences
Medical University of Lublin
Maria Sklodowska-Curie National Research Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

April 14, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGBRJG0108
  • KBN0655/P05/2005/28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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