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Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen

NCT03279289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-04-13

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen

Conditions

Interventions

DRUG

Aflibercept

4 mg/kg administered intravenous infusion on day 1

DRUG

Irinotecan

180 mg/m2 intravenous infusion

DRUG

folinic acid (dl racemic)

400 mg/m2 intravenous infusion

DRUG

5Fluorouracil

400 mg/m2 intravenous bolus

DRUG

5-FU

2400 mg/m2 continuous intravenous infusion over 46 hours

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Pilar García Alfonso · Hospital Universitario Gregorio Marañón

  • Javier Sastre Valera · Hospital Universitario Clínico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2023-02-09
Completion
2023-02-09

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03279289 on ClinicalTrials.gov