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

Kaunas University of Medicine150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Primary Rectal Cancer

Interventions

radiotherapyRADIATION

1. Short term radiotherapy 5x5 Gy during 5 days 2. Chemoradiotherapy 50 Gy + 5Fu/Lv

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

KMUH, surgery department

Kaunas, Lithuania

RECRUITING

Outcomes

Primary Outcomes

5 years overall and disease free survival

Time frame: 5 years

recurrence rate

Time frame: 5 years

Secondary Outcomes

pathological "complete response" and downstaging rates

Time frame: 5 years

Impact on sphincter sparing operation rates

Time frame: 5 years

morbidity and mortality rates

Time frame: 5 years

Impact on quality of surgical resection

Time frame: 5 years

Central Contacts

Tadas Latkauskas

CONTACT

+370 676 08901 tadas.latkauskas@kmuk.lt

Data from ClinicalTrials.gov

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