Timing for Rectal Surgery After Chemoradiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

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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Group 1

The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy

Group Type EXPERIMENTAL

Surgery after 12 weeks of delay after chemoradiotherapy.

Intervention Type PROCEDURE

Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.

Interventions

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Surgery after 12 weeks of delay after chemoradiotherapy.

Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No