Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer

(NO-CUT Trial)

Overseen By Salvatore Siena, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Niguarda Hospital

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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)

Treatment Details

Interventions

• Radiotherapy (Radiation)
• XELOX (Alkylating agents)

Participant Groups

Group I: Medium/low locally advanced rectal cancer Experimental Treatment 2 Interventions

Patients with Stage II (cT3-4 N0) or Stage III (cT1-4, N1-3) locally advanced rectal cancer amenable to Total Mesorectal Excision (TME)/Abdominal-Perineal Amputation

Radiotherapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

Niguarda Hospital

Lead Sponsor

Trials

76

Recruited

40,500+