Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer

Hospital Clinic of Barcelona1 site in 1 country911 target enrollmentFebruary 25, 2020

ConditionsRectal Cancer Neoadjuvant Therapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Hospital Clinic of Barcelona
Enrollment: 911
Locations: 1
Primary Endpoint: Distal resection margin (DRM)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.

Detailed Description

In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.

Registry

clinicaltrials.gov

Start Date

February 25, 2020

End Date

June 25, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hospital Clinic of Barcelona

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
•Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
•Patients treated with short-course radiotherapy with delayed surgery.
•Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging

Exclusion Criteria

•Intolerance or contraindication to planned NAT.
•Patients who have not finished NAT for any reason.
•Patients with unknown cT or cM.
•Tumors previously treated with local excision or with distant metastatic disease.