NCT03043950

Brief Summary

A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting (VALIDATE)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

7 years

First QC Date

February 2, 2017

Last Update Submit

April 23, 2024

Conditions

Metastatic Colorectal CancerRAS Wild-type

Keywords

mCRCFirst linePanitumumabmCCS Prognostic ScorePrognosisRas wild type

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS) of pre-defined risk groups low vs. high

    OS is defined as time from start of first line therapy to the date of death. For patients without date of start of first line therapy, date of informed consent will be the relevant date.

    From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

Secondary Outcomes (10)

  • Overall Survival (OS) of pre-defined risk groups low vs. intermediate

    From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

  • Overall Survival (OS) of pre-defined risk groups intermediate vs. high

    From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

  • Overall Survival (OS)

    From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

  • 2-years OS Rate (2-yrs OSR)

    at 24 months

  • Progression-free Survival (PFS)

    From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)

  • +5 more secondary outcomes

Other Outcomes (2)

  • Patient-reported general and health-related quality of life ('VALIDATE PRO')

    From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)

  • Adverse Drug Reactions

    From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)

Study Arms (3)

low risk

Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Drug: Panitumumab

medium risk

Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Drug: Panitumumab

high risk

High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Drug: Panitumumab

Interventions

PanitumumabDRUG

Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.

Also known as: + FOLFIRI or FOLFOX
high risklow riskmedium risk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with RAS-WT mCRC scheduled for the treatment with panitumumab and FOLFIRI or FOLFOX who have not received any prior systemic antineoplastic therapy in the palliative setting.

You may qualify if:

  • Eligibility according to current SmPC
  • Signed written informed consent
  • Diagnosis of RAS-WT mCRC
  • No prior systemic therapy in the palliative setting
  • Aged 18 years or older

You may not qualify if:

  • Any contraindication according to current SmPC
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

PanitumumabFolfox protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Norbert Marschner, Dr.

    Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 6, 2017

Study Start

January 25, 2017

Primary Completion

January 17, 2024

Study Completion

January 17, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)