Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

Ege University

Status: Completed

Conditions: Neoplasm, Rectum

Treatments: Procedure: Total mesorectal excision before 56 days (4-8 weeks); Procedure: Total mesorectal excision after 56 days (8-12 weeks)

Study type: Interventional

Funder types: Other

Identifiers

NCT03287843

17-4.1/13

Details and patient eligibility

About

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 will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.

Enrollment: 350 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
2. Patients with histologically confirmed adenocarcinoma of the rectum
3. Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
4. Standardized total mesorectal excision surgery
5. Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
6. Elective operation
7. The patient must consent to be in the study and the informed consent must be signed

Exclusion criteria

1. Clinic stage I and IV cancer disease
2. Patients with malignant disease of the rectum other than adenocarcinoma
3. Recurrent rectal cancer
4. Emergency cases (Mechanical bowel obstruction, perforation)
5. Other previous or concurrent malignancies
6. Any contraindication for radiochemotherapy
7. Previous chemotherapy or radiotherapy to the pelvis
8. Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
9. American Society of Anesthesiologists Score >3 patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Early surgery group

Experimental group

Description:

İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.

Treatment:

Procedure: Total mesorectal excision before 56 days (4-8 weeks)

Late surgery group

Experimental group

Description:

İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.

Treatment:

Procedure: Total mesorectal excision after 56 days (8-12 weeks)