Chemoradiation and Surgery vs Non-Operative Management for Rectal Cancer

Recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Experimental therapies

Disqualifiers: Recurrent cancer, Unresectable cancer, Thrombotic events, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

358 Participants Needed

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

Julio Garcia Aguilar, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Neoadjuvant Chemotherapy

Participants receive 8 cycles of FOLFOX or 5 cycles of CapeOX over approximately 15-16 weeks

15-16 weeks

Endoscopic exam 2-4 weeks after chemotherapy

Chemoradiation

Participants receive chemoradiation therapy with either 5-FU or capecitabine for 6 weeks

6 weeks

Endoscopic exam 2-4 weeks after chemoradiation

Consolidation Neoadjuvant Chemotherapy

Participants receive 8 cycles of FOLFOX or 6 cycles of CapeOX following chemoradiation

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in United States as Xeloda for:

• Colorectal cancer
• Breast cancer

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+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

St. Joseph, Florida

Collaborator

Trials

1

Recruited

360+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

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+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+