Primary Rectal Cancer
Conditions
Keywords
rectal cancer, radiotherapy, radiochemotherapy
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.
Interventions
RADIATIONradiotherapy
1. Short term radiotherapy 5x5 Gy during 5 days 2. Chemoradiotherapy 50 Gy + 5Fu/Lv
Sponsors
Kaunas University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 years overall and disease free survival | 5 years |
| recurrence rate | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Lithuania
Contacts
Primary ContactTadas Latkauskas
Outcome results
None listed