Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Phase 3
- Conditions
- Primary Rectal Cancer
- Interventions
- Radiation: radiotherapy
- Registration Number
- NCT00597311
- Lead Sponsor
- Kaunas University of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 radiotherapy preoperative short term radiation group 5x5 Gy and surgery after 6 weeks 2 radiotherapy preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
- Primary Outcome Measures
Name Time Method 5 years overall and disease free survival 5 years recurrence rate 5 years
- Secondary Outcome Measures
Name Time Method pathological "complete response" and downstaging rates 5 years Impact on sphincter sparing operation rates 5 years morbidity and mortality rates 5 years Impact on quality of surgical resection 5 years
Trial Locations
- Locations (1)
KMUH, surgery department
🇱🇹Kaunas, Lithuania