NCT03465982 Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
| NCT ID | NCT03465982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2018-06-05 |
| Primary Completion | 2025-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2018-06-05 with a primary completion date of 2025-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03465982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03465982 currently recruiting?
Yes, NCT03465982 is actively recruiting participants. Contact the research team at igor.monsellato@ospedale.al.it for enrollment information.
Where is the NCT03465982 trial being conducted?
This trial is being conducted at Alessandria, Italy, Forlì, Italy, Camposampiero, Italy, Negrar, Italy and 10 additional locations.
Who is sponsoring the NCT03465982 clinical trial?
NCT03465982 is sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. The trial plans to enroll 340 participants.
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