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Alkylating agent
Irinotecan + FOLFOX Chemotherapy for Rectal Cancer (JANUS Trial)
Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
JANUS Trial Summary
This trial compares effects of two chemo drugs to treat rectal cancer after radiation therapy. Results may help avoid surgery for some patients.
Who is the study for?
This trial is for adults with stage II-III rectal cancer, located within 12cm of the anal verge, who haven't had chemotherapy or radiation for colorectal cancer in the last 5 years. They must be healthy enough to participate (ECOG <=2), not pregnant or nursing, and willing to use effective contraception. People with certain heart conditions, HIV on effective treatment, and those not on strong CYP3A4 inhibitors/inducers are eligible.Check my eligibility
What is being tested?
The study tests if adding Irinotecan to standard FOLFOX chemotherapy after long-course radiation improves complete response rates and organ preservation in advanced-stage rectal cancer patients compared to using FOLFOX alone.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, fatigue, hair loss from Irinotecan; nerve damage (neuropathy), allergic reactions from Oxaliplatin; mouth sores and low blood counts from both chemotherapies.
JANUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clincal Complete Response (cCR) Rates
Secondary outcome measures
Disease-free survival (DFS) rate
Incidence of adverse events (AEs)
Organ-preservation-time (OPT)
+2 moreJANUS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (LCRT, FOLFIRINOX)Experimental Treatment10 Interventions
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.
Group II: Group I (LCRT, FOLFOX or CAPOX)Active Control9 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sigmoidoscopy
2007
Completed Phase 2
~140
Computed Tomography
2017
Completed Phase 2
~2720
biopsy
2002
Completed Phase 4
~8270
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Capecitabine
2013
Completed Phase 3
~3420
5-fluorouracil
2005
Completed Phase 4
~7960
Leucovorin calcium
2014
Completed Phase 3
~3620
Irinotecan
2017
Completed Phase 4
~2680
Oxaliplatin
2011
Completed Phase 4
~2560
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,326 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,542 Total Patients Enrolled
J. Joshua Smith, MDStudy ChairMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am HIV positive, on treatment, and my viral load has been undetectable for 6 months.My rectal cancer does not have mismatch repair deficiency.My rectal cancer is at a stage where it has grown deeply or spread to lymph nodes.I am not pregnant or breastfeeding.I am not taking strong CYP3A4 inhibitors, or I can stop them 14 days before the study.I am 18 years old or older.I am not taking strong CYP3A4 inducers, or I stopped them 14 days before starting the study.My rectal tumor is not located in the upper part of my rectum.My heart is healthy enough for this trial, based on a recent assessment.My rectal cancer is within 12cm of the anal opening.I haven't had chemo, targeted therapy, immunotherapy, or radiation for colorectal cancer in the last 5 years.I have not had recurrent rectal cancer or specific prior surgeries.I am not pregnant, will use effective birth control and a barrier method during the study, and for 9 months after.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (LCRT, FOLFOX or CAPOX)
- Group 2: Group II (LCRT, FOLFIRINOX)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications for participation in this experiment being accepted at present?
"Affirmative. Clinicaltrials.gov publicly states that this trial began its recruitment phase on December 8th 2022 and was last updated on January 4th 2023. This initiative is searching for a total of 312 participants from 2 distinct sites to participate in the study."
Answered by AI
What is the cap for enrollment in this clinical experiment?
"Affirmative, the clinical trial is open for enrollment according to information found on clinicaltrials.gov - which was last updated on January 4th 2023. This study requires 312 individuals from 2 different sites and first posted online December 8th 2022."
Answered by AI
Has the United States Food and Drug Administration sanctioned Group II (LCRT, FOLFIRINOX) for therapeutic use?
"Taking into consideration the Phase 2 status of Group II (LCRT, FOLFIRINOX), our team assigned it a safety score of 2 due to existing evidence supporting its security though no studies have proven effectiveness."
Answered by AI
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