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Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer

NCT01991873 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2023-06-15

No results posted yet for this study

Summary

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy.

Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.

Conditions

Interventions

DRUG

Maintenance Chemotherapy

DRUG

Panitumumab (Within maintenance phase)

DRUG

mFOLFOX6 (Within re-induction phase)

DRUG

Panitumumab (Within re-induction phase)

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Tanja Trarbach, Dr. med. · Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2023-02-18
Completion
2023-02-18

Countries

  • Germany

Study Locations

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Entities

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 NCT01991873 on ClinicalTrials.gov