FOLFOX Chemotherapy for Rectal Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Richard Dunne, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Rochester

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.

Eligibility Criteria

Adults diagnosed with locally advanced rectal cancer who haven't had previous treatments or radiation, and have no history of other cancers in the last 3 years. They must meet specific blood work criteria, not be pregnant or planning to conceive, and agree to use contraception. Those with certain heart conditions, active infections, or peripheral neuropathy are excluded.

Inclusion Criteria

Platelet count>100,000/mm3

Baseline lab work must meet the following parameters:

I do not have any infections needing IV antibiotics.

Exclusion Criteria

I do not have heart, liver, or kidney diseases that would prevent me from receiving chemotherapy.

My cancer is at a specific stage and size.

I do not have severe numbness or pain in my hands or feet.

Participant Groups

The trial is testing FOLFOX chemotherapy without radiation and surgery for complete response in treating locally advanced rectal cancer. It aims to see if patients can achieve remission with this approach alone.

Group I: mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin) Experimental Treatment 1 Intervention

Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.

FOLFOX is already approved in United States, European Union, Japan, China for the following indications:

🇺🇸 Approved in United States as FOLFOX for:

• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction adenocarcinoma

🇪🇺 Approved in European Union as FOLFOX for:

• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction adenocarcinoma

🇯🇵 Approved in Japan as FOLFOX for:

• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction adenocarcinoma

🇨🇳 Approved in China as FOLFOX for:

• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction adenocarcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Rochester, James P. Wilmot Cancer Center Rochester, NY

University of Rochester Rochester, NY

Who Is Running the Clinical Trial?

University of Rochester Lead Sponsor

References