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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response

Study acronym: JANUS
StatusActive, Not Recruiting
PhasePhase 2/3
Started2022-12-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 45 months later Sep 30, 2026 → Jul 1, 2030
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Alliance for Clinical Trials in Oncology

Amendment history

2026-08-31
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v18
Primary completion pushed: 2026-09-30 → 2030-07-01
Completion pushed: 2033-09-30 → 2037-07-01
Phase changed: Phase 2 → Phase 2/3
Primary endpoint(s) modified1 to 2 entries
WasClincal Complete Response (cCR) Rates
NowClincal Complete Response (cCR) Rates (Phase II), Disease-free survival (DFS) rate (Phase III)
Enrollment target783→760
Eligibility criteria+1,121 characters
Inclusion Criteria: Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR) Stage: Clinical stage II or III rectal adenocarcinoma define [...] resection (APR) or coloanal anastomosis Tumor site: Rectum; distal edge of the tumor =< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment) No prior systemic chemotherapy, targeted therapy, or immuno [...] ent for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal can [...] [...]
Secondary endpoints5 entries, revised
Disease-free survival (DFS) rate Organ-preservation- time (OPT) Sustained cCR
Study description+807 characters
PRIMARY OBJECTIVEOBJECTIVES: I. To evaluate and compare the clinical complete response [...] advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified leucovorin fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT foll [...] dified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6)/CAPOX (Phase II). II. To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed [...] [...]
Study sitesdetails revised at 2 of 685 sites
Study title+24 characters
[...] Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
2025-09-05
Study Status v17
Primary completion date2025-09-30→2026-09-30
Completion date2032-09-30→2033-09-30
2025-08-28
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 312→confirmed 783
Study sites681→685
2025-06-24
Study Status, Contacts/Locations v15
Study sites662→681
2025-03-28
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v14
Study sites642→662
Show 13 earlier versions
2025-01-09
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v13
Primary completion date2025-09→2025-09-30
Completion date2032-09→2032-09-30
Study sitesdetails revised at 619 of 642 sites
2024-12-24
Study Status, Contacts/Locations v12
Study sites636→642
2024-10-24
Study Status, Contacts/Locations v11
Primary completion date2024-09→2025-09
Study sites630→636
2024-08-01
Study Status, Contacts/Locations v10
Study sites620→630
2024-05-22
Study Status, Contacts/Locations v9
Study sites590→620
2024-04-08
Study Status, Contacts/Locations v8
Study sites574→590
2024-02-19
Study Status, Contacts/Locations v7
Study sites333→574
2023-10-30
Study Status, Contacts/Locations v6
Study sites286→333
2023-08-30
Study Status, Contacts/Locations v5
Study sites267→286
2023-07-20
Study Status, Contacts/Locations v4
Study sites219→267
2023-05-16
Study Status, Contacts/Locations v3
Study sites122→219
2023-03-23
Study Status, Contacts/Locations v2
Study sites2→122
2023-01-04
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11-09→confirmed 2022-12-08
Study sites0→2
Eligibility criteria+21 characters
Inclusion Criteria: Stage: Clinical stage II or III rectal adenocarcinoma define [...] ophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 50 mL/min ^3 Total bilirubin =< 1.5 x upper limit of normal (ULN) Asparta [...]
2022-11-02
Original filing
This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy regimens, such as FOLFIRINOX (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, and oxaliplatin), or CAPOX (capecitabine and oxaliplatin) use more than one anticancer drug that 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 for the primary rectal tumor and lead to higher rates of clinical complete response (and thus a chance to avoid surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Trial Details
NCT Number NCT05610163
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Locally Advanced Rectal Adenocarcinoma
Enrollment 760 participants
Start Date 2022-12-08
Primary Completion 2030-07-01 (estimated)
Study Completion 2037-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-25