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Preoperative Radiotherapy and Local Excision in Rectal Cancer

NCT00738790 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2010-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Short course of radiotherapy

5 x 5 Gy plus boost 4 Gy

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)

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    collaborator OTHER

  • Poznan University of Medical Sciences

    collaborator OTHER

  • Medical University of Lublin

    collaborator OTHER

  • Polish Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Krzysztof Bujko, Prof. · Roentgena 5, 02-781 Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2010-11-30
Completion
2013-11-30

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00738790 on ClinicalTrials.gov