CompletedPhase 2

Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer

Italy180 participantsStarted 2018-06-01

Plain-language summary

NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in patients with operable rectal cancer, without increasing the risk of distant relapse. The trial also has a translational component aimed at establishing whether selected genomic, epigenetic, and transcriptomic markers are predictive of tumor and patient outcome.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the medium/lower rectum * Patients must have Stage II (cT3-4 N0) or Stage III (cT1-4, N1-3) tumor * Locally advanced rectal cancer amenable to Total Mesorectal Excision (TME)/Abdominal-Perineal Amputation * No evidence of distant metastases by chest, abdomen, and pelvis contrast enhanced CT scan (TC-positron emission computed tomography (PET) Whole Body (WB) is acceptable alternative in patient allergic to iodate contrast medium) * No prior pelvic radiation therapy * No prior oncologic medical therapy or surgery for rectal cancer * Age \>18 years * No infections requiring systemic antibiotic treatment * Performance status 0-1 (ECOG Scale) * absolute neutrophil count (ANC) \> 1.5 cell/mm3, Hb\>8.0 g/ dL, Platelet Count (PLT)\>150,000/mm3, total bilirubin \< or equal or 1.5 x upper limit of normal, Aspartate Aminotransferase (AST) \< or equal to three times upper limit of normal, Alanine Aminotransferase (ALT)\< or equal to three times upper limit of normal; Serum creatinine level \< or equal to 1.5 times the upper limit of normal * Patients must read, agree to, and sign a statement of Informed Consent prior to participation * Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive methods * Male subjects must also agree to use effective contraception Exclusion Criteria: * Recurrent rectal cancer * Patients with a history o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Distant Relapse-Free Survival (DRFS)

Timeframe: 2.5 years

Trial details

NCT IDNCT03565029

SponsorNiguarda Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-31

View on ClinicalTrials.gov More Colo-rectal Cancer trials