Clinical Trials for Cancer Treatment

Study Title:

A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

What is the purpose of the study? (in Layman's terms, please describe the study)

This study is being done to see if the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) for patients with locally advanced rectal cancer can be increased by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation, and if that approach is better or worse than the usual approach. The usual approach for patients who are not in a study is treatment with chemoradiation followed by radical surgery then possibly chemotherapy (FDA-approved) after surgery or a combination of chemotherapy (FDA-approved) then chemoradiation then radical surgery.

Upstate Institutional Review Board (IRB) Number:

2035335

Study/Protocol ID:

A022104

Study Phase:

Patient Age Group:

Adults

Principal Investigator:

Rahul Seth, DO

What is involved if I participate?

How long is the study?
5 years
Is transportation provided or reimbursed?
No
Is parking provided or reimbursed?
No
What tests and procedures are involved?
Digital rectal exams, colonoscopies, scans (CTs and MRIs), blood tests