Chemoradiation and Surgery vs Non-Operative Management for Rectal Cancer

Palo Alto (17 mi)

Overseen byJulio 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).

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.

My diagnosis is rectal adenocarcinoma.

My cancer has not spread to distant parts of my body.

I have not had chemotherapy or surgery for rectal cancer.

I am at least 18 years old, or 19 if living in certain Canadian provinces.

I can take care of myself and am up and about more than half of my waking hours.

I have not had radiation therapy to my pelvic area.

Exclusion Criteria

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

My rectal cancer cannot be surgically removed due to its spread to nearby organs.

I have had radiation therapy to my pelvic area before.

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

I am not pregnant or breast-feeding.

My rectal cancer has come back.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Group I: INCTExperimental Treatment7 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: CNCTExperimental Treatment7 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: