- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00597311
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
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 Contact
- Name: Tadas Latkauskas
- Phone Number: +370 676 08901
- Email: tadas.latkauskas@kmuk.lt
Study Locations
-
-
-
Kaunas, Lithuania, LT3000
- Recruiting
- KMUH, surgery department
-
Contact:
- Tadas Latkauskas
- Phone Number: +370 676 08901
- Email: tadas.latkauskas@kmuk.lt
-
-
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
|
|
Experimental: 2
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
|
|
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
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.
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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