West Cancer Center

RECTAL: ADJUVANT: POST RT: FOLFIRINOX: JANUS

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

Title

Alliance A022104 (JANUS Rectal Trial)

Study Title

Site Link

NCT05610163

Malignancy

Rectal cancer, CRC

Stage

Stage 2

Disease Setting

Adjuvant, post radiation

Line Of Therapy

Adjuvant

Investigational Agent

FOLFIRINOX

Drug Class

Chemotherapy

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Clinical stage II or III rectal adenoCA defined as T4N0 or any T with node positive disease. T3N0 requiring APR or coloanal astamosis is also allowed
No prior systemic non-surgical treatment for rectal cancer within last 5 years
ECOG PS 0-2
No upper rectal tumors (>12 cm above anal verge)
No recurrent rectal cancer
No known MMR deficient cancer

Objective

Primary
- Clinical complete response rate
Secondary
- Organ preservation time
- DFS
- time to distant metastases
- OS
- Toxicity

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes