Chemoradiation and Surgery vs Non-Operative Management for Rectal Cancer

Recruiting at26 trial locations

Overseen by Julio Garcia Aguilar, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).

Research Team

Julio Garcia Aguilar, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with locally advanced rectal cancer who haven't had previous treatments like chemotherapy, surgery, or pelvic radiation. They should be generally healthy without active infections and no history of certain cancers in the past 5 years. Women must not be pregnant and agree to use contraception.

Inclusion Criteria

My cancer is at Stage II or III according to MRI results.

My rectal cancer needs a total mesorectal excision.

Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand English are eligible and may be consented according to institutional and federal regulations.

Exclusion Criteria

I have had a heart attack, stroke, or severe chest pain in the last 6 months.

I am not currently on any other cancer treatments or experimental drugs.

Creatinine level greater than 1.5 times the upper limit of normal.

Treatment Details

Interventions

• 5-Fluorouracil (5-FU) (Chemotherapy)
• Capecitabine (Chemotherapy)
• DRE-Endoscopy (Procedure)
• Intensity Modulated Radiotherapy (IMRT) (Radiation)
• Leucovorin (Chemotherapy)
• Oxaliplatin (Chemotherapy)

Trial Overview The study tests if a complete treatment before surgery (TNT) followed by either total mesorectal excision (TME) or non-operative management (NOM) improves disease-free survival over standard chemoradiation therapy plus TME and additional chemotherapy.

Participant Groups

Group I: INCT Experimental Treatment 7 Interventions

Arm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.

Group II: CNCT Experimental Treatment 7 Interventions

Arm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.

Capecitabine is already approved in Canada, Japan for the following indications:

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

Neil J. Weissman

Medstar Health Research Institute

Chief Executive Officer since 2018

Medical degree from Cornell University Medical College

Stephen R.T. Evans

Medstar Health Research Institute

Chief Medical Officer since 2018

MD

St. Joseph, Florida

Collaborator

Trials

1

Recruited

360+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

Dr. Dragos Banu

University of Vermont

Chief Medical Officer

MD from Saba University School of Medicine

Dr. Richard Page

University of Vermont

Chief Executive Officer since 2018

MD from Duke University

John Muir Health

Collaborator

Trials

3

Recruited

550+

Colon and Rectal Surgery Inc.

Industry Sponsor

Trials

1

Recruited

360+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Dr. Barbara White

University of South Florida

Chief Medical Officer since 2021

MD, University of Pennsylvania School of Medicine

Dr. Sylvia W. Thomas

University of South Florida

Chief Executive Officer since 2023

Ph.D. in Electrical Engineering, University of South Florida

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine