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

Kaunas University of Medicine

Status and phase: Unknown; Phase 3

Conditions: Primary Rectal Cancer

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00597311

BE-2-48

137/2006

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Experimental group

Description:

preoperative short term radiation group 5x5 Gy and surgery after 6 weeks

Treatment:

Radiation: radiotherapy

2

Experimental group

Description:

preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.

Treatment:

Radiation: radiotherapy