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Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

NCT03465982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-04-16

No results posted yet for this study

Summary

The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.

Conditions

Interventions

PROCEDURE

Surgery after 8 weeks from chemoradiation treatment

Minimally invasive surgery after 8 weeks from chemoradiation treatment

PROCEDURE

Surgery after 12 weeks from chemoradiation treatment

Minimally invasive surgery after 12 weeks from chemoradiation treatment

Sponsors & Collaborators

  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2025-06-05
Completion
2029-06-05

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465982 on ClinicalTrials.gov