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 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.
- 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?
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
- 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 ACCRUAL