Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Launched by AZIENDA OSPEDALIERA SS. ANTONIO E BIAGIO E CESARE ARRIGO DI ALESSANDRIA · Mar 8, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating the best timing for performing surgery to treat rectal cancer after patients have received a combination of chemotherapy and radiation therapy. Specifically, it compares two groups: one group will have surgery 8 weeks after their treatment, while the other group will wait 12 weeks. The goal is to see if the timing of the surgery affects the overall success of the treatment. A total of 332 patients will be involved in this trial across multiple locations, and they will be followed for 5 years after their treatment.

To qualify for this trial, participants need to be at least 18 years old and have a specific type of rectal cancer that can be treated with surgery. They should also be able to undergo a minimally invasive surgical procedure, which is less invasive than traditional surgery and often leads to quicker recovery times. Participants will need to give their consent and complete some questionnaires. It's important to note that certain conditions, like having metastatic (spread) cancer or previous treatments that may affect participation, would exclude someone from the trial. Overall, this study aims to find the most effective approach to surgery timing to improve outcomes for patients with rectal cancer.

Gender

ALL

Eligibility criteria

• 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