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Status unknownNCT05354817Re-PlayUpdated Apr 29, 2022

Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

A Phase 2 interventional study of mFOLFIRINOX in Colorectal Cancer Stage IV, sponsored by Instituto do Cancer do Estado de São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by Instituto do Cancer do Estado de São Paulo · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2021, registered Apr 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS.

Currently at ICESP, patients are frequently re-exposed in third line to double combinations.

Read the detailed description

Single-arm phase II study. The chemotherapy regimen with mFOLFIRINOX will be administered every 14 for 4 cycles, after evaluation of tumor response, you can maintain treatment until disease progression.

The FOLFIRINOX regimen, as well as the drugs used (oxaliplatin, 5-Fluorouracil, leucovorin and irinotecan) is already indicated in the package insert for the treatment of colorectal cancer.

If treatment is discontinued after cycle 4 with the patient responding, for response maximum or unmanageable toxicity, it is suggested to maintain imaging control every 60 days (7-day window) until disease progression. This interval is already commonly used for patients with metastatic disease who are on treatment pause. Treatment in progression of illness will be at the discretion of the treating physician. Cancer patients undergoing chemotherapy routinely perform evaluation of organ functions and CEA, as well as clinical evaluation before each cycle of treatment

02

Conditions studied

  • Colorectal Cancer Stage IV

Keywords

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 25 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Instituto do Cancer do Estado de São Paulo is the lead sponsor of 90 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of metastatic colon/rectal adenocarcinoma, with measurable by RECIST v. 1.1
  • Disease progression to at least two lines of chemotherapy with chemotherapy regimens that contain fluoropyrimidine, irinotecan and oxaliplatin
  • Patients with RAS research in tumor sample with result wild animals must have previously received anti-EFGR therapy.
  • ECOG (Eastern Cooperative Oncology Group) 0 or 1
  • Availability of tumor material for molecular analysis
  • Hb > 8, neutrophils > 1,500 and PLQ > 100,000
  • Adequate kidney and liver function

Exclusion criteria

Exclusion Criteria:

  • Active neoplasm with other primary site, except in situ tumors
  • Contraindication to treatment with fluoropyrimidine, oxaliplatin and irinotecan, including previous unmanageable G3 or greater toxicities, in previous exhibitions.
  • Presence of comorbidities that, according to the investigator's assessment, may compromise participant safety
  • Prior exposure to the FOLFIRINOX regimen
  • Pregnant or lactating women
  • Total bilirubin above 1.5mg/dL
  • Hepatic transaminases greater than 3 times the upper limit of normality
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    mFolfirinox

    Drug: mFOLFIRINOX

Interventions

  • DrugmFOLFIRINOX

    mFOLFIRINOX: - Oxaliplatin; Leucovorin; Irinotecan and 5-FU

06

What researchers measure

Primary outcomes

  1. Assess response rate after 4 cycles of FOLFIRINOX

    Time frame: 2 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 2 years

  2. Overall Survival

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • ICESP
    Sao Paulo, SP 01246000, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05354817
Lead sponsor
Instituto do Cancer do Estado de São Paulo
Responsible party
Sponsor
First posted
Apr 29, 2022
Start date
Oct 22, 2021
Primary completion
Dec 2022 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 29, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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