JanusRectalCancerTrial: PhII TripletVSDoublet ChemoClinicalComplete Response Pa w/LocallyAdvRectalCa

Cancer
Jason Zell
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
Rectum

Study Description

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Eligibility

Inclusion Criteria:

-Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis

-Tumor site: Rectum; =< 12cm from the anal verge

-No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed

-Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

  • Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for >= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for >= 6 months after the last treatment

-No upper rectal tumors (distal margin of tumor > 12 cm from the anal verge)

-No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis

-No known mismatch repair deficient rectal adenocarcinoma

-Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial

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