Status:
COMPLETED
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Rectal Neoplasm Malignant
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Mai...
Detailed Description
Patients harbouring rectal adenocarcinoma T3-4 or N\>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolu...
Eligibility Criteria
Inclusion
- Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1.
Exclusion
- Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent.
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Key Trial Info
Start Date :
January 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03428529
Start Date
January 12 2011
End Date
December 13 2016
Last Update
February 9 2018
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