Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study

ConditionsNeoplasm Malignant Colon Cancer Stage 4

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAl-Azhar University

About this trial

This prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. .

The primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance.

This study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients were required to have measurable disease according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (Eisenhauer EA,2009)

ECOG PS 0-1 better to exclude PS II as this protocol is known to be toxic

Adequate baseline hematology and clinical chemistry labs

Adequate cardiac function

Disqualifiers

Double Malignancy

DPYD mutant patients

Peripheral neuropathy grade 3 or higher patient due to other comorbidities

Inflammatory bowel syndrome or any other chronic GIT disease

Trial design

Design model

Single group

Treatments tested in this trial

FOLFOXIRI Protocol
Drug
as mentioned in Arm description

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: modified FOLFOXIRI plus target therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Treatment-related adverse events

evaluate treatment-related acute and delayed toxicity

Time frame

12 months

Objective Response Rate

To assess the impact of the treatment on the objective response rate

Time frame

6 months

Secondary outcomes

Conversion therapy

To assess the treatment's efficacy as a conversion therapy, transforming initially unresectable tumors to resectable ones, response rates will be evaluated every 4 treatment cycles according to RECIST v1.1 (Eisenhauer EA, 2009): Complete Response (CR): Disappearance of all lesions and pathological lymph nodes. Partial Response (PR): ≥30% decrease in the sum of the longest diameters (SLD) of target lesions, no new lesions, and no progression in non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): ≥20% increase in SLD or the appearance of new lesions. Patients eligible for surgery may receive up to 8 cycles before surgical evaluation. Those showing favorable response will be referred for potential surgical intervention.

Time frame

4 months

Progression free survival

to study the impact of treatment on progression free survival

Time frame

12 months

Overall survival

to study the impact of treatment on overall survival

Time frame

24 months

Other outcomes

Prognostic and predictive values

To evaluate predictive and prognostic factors of significance and its impact ORR, PFS and OS

Time frame

24 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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