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

Phase 3

• Conditions: Primary Rectal Cancer

• 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

Study Timeline

• Study Start: 2007-01
• Status Verified: 2008-01
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Last Update Submitted: 2008-01-09
• Study First Posted: 2008-01-18
• Last Update Posted: 2008-01-18
• Primary Completion: 2012-01
• Study Completion: 2012-01

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

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