A022104 (JANUS): Locally Advanced Rectal Cancer

Purpose of this Study

We are doing this study to compare the standard treatments (FOLFOX or CAPOX after chemoradiation) for rectal cancer to a drug regimen called FOLFIRINOX that is given after chemoradiation. We want to know if FOLFIRINOX after chemoradiation can provide better outcomes than either of the 2 standard treatments.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with Stage II or III rectal adenocarcinoma
  • Have not received previous systemic chemotherapy, targeted therapy, immunotherapy, or radiation therapy administered to treat colorectal cancer within the past 5 years
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group will get the standard drugs used to treat this type of cancer (FOLFOX or CAPOX) after long-course chemoradiation
  • The other group will get a drug regimen called FOLFIRINOX after long-course chemoradiation
FOLFOX (Leucovorin, 5-Fluorouracil, Oxaliplatin): If you receive this drug regimen, you will get these drugs through a vein in the arm on day 1 of each drug cycle. Each cycle lasts 14 days and you will undergo 8 cycles. CAPOX (Capecitabine, Oxaliplatin): If you receive this drug regimen, you will get oxaliplatin through a vein in the arm on day 1 of each cycle and you will take capecitabine by mouth on days 1-14 of each cycle. Each cycle lasts 21 days and you will undergo 5 cycles. FOLFIRINOX (Leucovorin, 5-Fluorouracil, Irinotecan, Oxaliplatin): If you receive this drug regimen, you will get these drugs through a vein in the arm on day 1 of each drug cycle. Each cycle lasts 14 days and you will undergo 8 cycles.

Study Details

Full Title

A022104: The Janus Rectal Cancer Trial: 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

Principal Investigator

Aman
Opneja

Protocol Number

PRO00113244

NCT ID

NCT05610163

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov