Group II (LCRT, FOLFIRINOX) for Rectal Cancer

OptumCare Cancer Care at Charleston, Las Vegas, NV
Rectal Cancer+2 More Conditionsbiopsy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares effects of two chemo drugs to treat rectal cancer after radiation therapy. Results may help avoid surgery for some patients.

Eligible Conditions
  • Rectal Cancer
  • Stage III Rectal Cancer
  • Stage II Rectal Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Year 5
Organ-preservation-time (OPT)
Year 5
Overall survival (OS)
Year 5
Time to distant metastasis (TDM)
Up to 5 years
Clincal Complete Response (cCR) Rates
Incidence of adverse events (AEs)
Year 5
Disease-free survival (DFS) rate

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group I (LCRT, FOLFOX or CAPOX)
1 of 2
Group II (LCRT, FOLFIRINOX)
1 of 2

Active Control

Experimental Treatment

312 Total Participants · 2 Treatment Groups

Primary Treatment: Group II (LCRT, FOLFIRINOX) · No Placebo Group · Phase 2

Group II (LCRT, FOLFIRINOX)Experimental Group · 10 Interventions: biopsy, Capecitabine, Leucovorin calcium, 5-fluorouracil, Irinotecan, Computed Tomography, Long Course Chemoradiotherapy, Oxaliplatin, Sigmoidoscopy, Magnetic Resonance Imaging · Intervention Types: Procedure, Drug, Drug, Drug, Drug, Procedure, Radiation, Drug, Procedure, Procedure
Group I (LCRT, FOLFOX or CAPOX)ActiveComparator Group · 9 Interventions: biopsy, Capecitabine, Leucovorin calcium, 5-fluorouracil, Computed Tomography, Long Course Chemoradiotherapy, Oxaliplatin, Sigmoidoscopy, Magnetic Resonance Imaging · Intervention Types: Procedure, Drug, Drug, Drug, Procedure, Radiation, Drug, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
biopsy
2002
Completed Phase 4
~5750
Capecitabine
2002
Completed Phase 3
~3230
Leucovorin calcium
2014
Completed Phase 3
~3620
5-fluorouracil
2005
Completed Phase 4
~7960
Irinotecan
2017
Completed Phase 4
~3950
Computed Tomography
2017
Completed Phase 2
~2710
Oxaliplatin
2011
Completed Phase 4
~1990
Sigmoidoscopy
2007
Completed Phase 2
~140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,416 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
507 Previous Clinical Trials
218,328 Total Patients Enrolled
J. Joshua Smith, MDStudy ChairMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not had rectal cancer return, and you have not had surgery to remove cancer from your lower colon.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.