NCT05610163|Active Not RecruitingPhase 2DMC

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

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

A022104NCI-2022-07800U10CA180821NRG-GI010

Study Type

interventional

Target

783

Locations

2 countries

Sites

685

Timeline

RegisteredNov 2022

StartedDec 2022

CompletionSep 2033

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

783

participants targeted

Target at P75+ for phase_2

Timeline

90mo left

Started Dec 2022

Longer than P75 for phase_2

Geographic Reach

2 countries

685 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.8 years study duration

Study Progress32%

Dec 2022Sep 2033

First Submitted

Initial submission to the registry

November 1, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed

29 days until next milestone

Study Start

First participant enrolled

December 8, 2022

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected

7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2033

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

November 1, 2022

Last Update Submit

September 5, 2025

Conditions

Locally Advanced Rectal Carcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Clincal Complete Response (cCR) Rates
efined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If the tumor has evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. divided by number of patients included in the analysis population.
Up to 5 years

Secondary Outcomes (5)

Disease-free survival (DFS) rate
rom date of randomization, assessed up to 5 years
Organ-preservation-time (OPT)
From date of randomization, assessed up to 5 years
Time to distant metastasis (TDM)
From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years
Overall survival (OS)
From the date of randomization to the date of death due to all causes, assessed up to 5 years
Incidence of adverse events (AEs)
Up to 5 years

Study Arms (2)

Group I (LCRT, FOLFOX or CAPOX)

ACTIVE COMPARATOR

Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.

Drug: CapecitabineDrug: 5-fluorouracilDrug: Leucovorin calciumDrug: OxaliplatinRadiation: Long Course ChemoradiotherapyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: SigmoidoscopyProcedure: biopsy

Group II (LCRT, FOLFIRINOX)

EXPERIMENTAL

Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

Drug: CapecitabineDrug: 5-fluorouracilDrug: Leucovorin calciumDrug: IrinotecanDrug: OxaliplatinRadiation: Long Course ChemoradiotherapyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: SigmoidoscopyProcedure: biopsy