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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm, Rectum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early surgery group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Low anterior resection or abdominoperineal resection

Late surgery group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Low anterior resection or abdominoperineal resection

Interventions

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

Low anterior resection or abdominoperineal resection

Intervention Type PROCEDURE

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

Low anterior resection or abdominoperineal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No