Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

January 9, 2008 updated by: Kaunas University of Medicine
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
  • less than 80 years old
  • no other cancer during 5 years period
  • compensate cardiovascular, pulmonary, hepatic and renal functions.

Exclusion Criteria:

  • stage I or IV rectal cancer
  • other cancer in 5 years period
  • radiotherapy or chemotherapy in anamnesis
  • not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
  • pregnancy or baby feeding

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 short term radiation group 5x5 Gy and surgery after 6 weeks
Radiation: radiotherapy
  1. Short term radiotherapy 5x5 Gy during 5 days
  2. Chemoradiotherapy 50 Gy + 5Fu/Lv
Experimental: 2
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
Radiation: radiotherapy
  1. Short term radiotherapy 5x5 Gy during 5 days
  2. Chemoradiotherapy 50 Gy + 5Fu/Lv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence rate
Time Frame: 5 years
5 years
5 years overall and disease free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
pathological "complete response" and downstaging rates
Time Frame: 5 years
5 years
Impact on sphincter sparing operation rates
Time Frame: 5 years
5 years
morbidity and mortality rates
Time Frame: 5 years
5 years
Impact on quality of surgical resection
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Kaunas University of Medicine

Investigators

  • Principal Investigator: Dainius Pavalkis, professor, Kaunas Medical University

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

January 1, 2007

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2008

Last Update Submitted That Met QC Criteria

January 9, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-2-48
  • 137/2006

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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