Timing of Surgery After Chemoradiotherapy for Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares the outcomes of robotic-assisted or standard laparoscopic rectal cancer surgery performed either 8 weeks or 12 weeks after neoadjuvant chemoradiotherapy. It aims to determine if delaying surgery affects the rate of pathological complete response (pCR) and improves disease-free survival (DFS) and overall survival (OS). The study will enroll 332 patients across multiple centers, with a follow-up period extending 5 years after the last patient is randomized. Participants will be randomized after providing consent and completing baseline questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>18 years
* cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
* Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
* Histologically-proven adenocarcinoma of the rectum
* Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
* Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)
* Eligible for chemoradiation treatment
* Able to give written informed consent
* Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)

Exclusion Criteria:

* Metastatic disease
* Squamous carcinoma of the anal canal
* Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
* History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
* Pregnancy
* Unable to complete neoadjuvant treatment
* Unable to give free informed consent
* Previous radiation treatment on the pelvis
* Inflammatory bowel disease
* Hereditary colorectal disease
* Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer
* Participation in another rectal cancer clinical trial relating to the topic of this trial

Where it's running

• SS. Antonio e Biagio e Cesare Arrigo Hospital
  Alessandria, Al, Italy Recruiting
• Ospedale Gian Battista Morgagni - Luigi Pierantoni
  Forlì, Forlì-Cesena, Italy Recruiting
• Ospedale Civile Pietro Cosma
  Camposampiero, Padua, Italy Recruiting
• Ospedale Sacro Cuore
  Negrar, Verona, Italy Recruiting
• Ospedale degli Infermi
  Biella, Italy Recruiting
• Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
  Brescia, Italy Recruiting

Study contacts

• Study coordinator: Igor Monsellato, MD
• Email: igor.monsellato@ospedale.al.it
• Phone: +390131206506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.