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PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part in this study, you will get long-course chemoradiation (usual treatment) for up to 5 weeks. Then you will either receive the usual treatment with FOLFOX (8 cycles, each cycle is 2 weeks) or CAPOX (5 cycles, each cycle is 3 weeks) or you will receive the study treatment with FOLFIRINOX for 8 cycles (each cycle is 2 weeks). After you finish your treatment, your doctor will continue to follow your condition and watch you for side effects. They will check you about every 4 months for 2 years after treatment. After that, they will check you about every 6 months for 3 years. This means you will keep seeing your doctor for 5 years after treatment.

Total length of participation:
2-5 years

Looking for Specific Volunteers

Able to participate:

Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+)
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
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis

Not eligible if:

None

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Hanna Sanoff
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)

IRB Number

22-3319

ClinicalTrials.gov

NCT05610163

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