Timing for Rectal Surgery After Chemoradiotherapy

Timing for Rectal Surgery After ChST

NCT03607370•National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Summary

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks. Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Over 18 years old
•Eastern Cooperative Oncology Group (ECOG) 0-1,
•American Society of Anesthesiologists' (ASA) score I-III
•Histological confirmation of adenocarcinoma of rectum
•T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan
•Undergoing preoperative radiotherapy/ chemotherapy
•Curative total mesorectal excision intended
•Written informed consent
•Patients undergoing preoperative radiotherapy should not be excluded

Exclusion Criteria

•Patients with distant metastasis
•T1 or T2, N0 cancer on MRI
•Rectal cancer 12 cm above the dentate line
•Contraindications to MRI
•Patients previously treated of pelvic organ cancer
•Medical or psychiatric conditions that compromise the patients ability to give informed consent

Locations (1)

National Cancer Institute

Vilnius, Lithuania

Key Dates

Start Date

July 1, 2017

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2025

Last Updated

November 8, 2023

Enrollment

142

ACTUAL participants

Conditions

Rectal Cancer

Interventions

Surgery after 12 weeks of delay after chemoradiotherapy.

PROCEDURE

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Timing for Rectal Surgery After Chemoradiotherapy

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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