A022104 (JANUS): Locally Advanced Rectal Cancer

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.

Advanced Rectal Cancer

• Adults 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.

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