Status:
COMPLETED
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Lead Sponsor:
Ege University
Conditions:
Neoplasm, Rectum
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants...
Eligibility Criteria
Inclusion
- Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
- Patients with histologically confirmed adenocarcinoma of the rectum
- Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
- Standardized total mesorectal excision surgery
- Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
- Elective operation
- The patient must consent to be in the study and the informed consent must be signed
Exclusion
- Clinic stage I and IV cancer disease
- Patients with malignant disease of the rectum other than adenocarcinoma
- Recurrent rectal cancer
- Emergency cases (Mechanical bowel obstruction, perforation)
- Other previous or concurrent malignancies
- Any contraindication for radiochemotherapy
- Previous chemotherapy or radiotherapy to the pelvis
- Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
- American Society of Anesthesiologists Score \>3 patients
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03287843
Start Date
January 1 2006
End Date
January 1 2022
Last Update
March 31 2022
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