Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix® and FOLFIRI or FOLFOX in First Line (VALIDATE) (VALIDATE)

April 23, 2024 updated by: iOMEDICO AG

A Non-interventional Study to Assess the Safety and Efficacy of First Line Therapy With Vectibix® in Combination With FOLFIRI or FOLFOX and to Validate a Prognostic Score in Adult Patients With RAS Wild-type Metastatic Colorectal Cancer in a Real World Setting (VALIDATE)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter study in Germany and Austria. In total, 606 patients will be enrolled in approx. 120 oncological sites (office-based medical oncologists, oncology outpatient-centers, and university hospitals) in a time period of 48 months. Of these, 202 patients with high risk, 202 patients with intermediate risk, and 202 patients with low risk, as a priori assessed by the metastatic colorectal cancer prognostic score (mCCS), will be included. Overall survival of the pre-defined prognostic groups will be analyzed as primary endpoint to validate the mCCS.

Patients have been scheduled to receive first line combination therapy with panitumumab and FOLFIRI or FOLFOX according to the current SmPC valid for Germany and Austria, respectively. Data on efficacy in terms of tumor response evaluation / survival and safety (ADRs) will be collected during first line therapy. A subset of patients participating in the 'VALIDATE-PRO' project (n=303) will be assessed for general and health-related quality of life with patient questionnaires. Biomarker status beyond RAS will be collected at baseline. The documentation of defined patient data including survival will continue until the end of the individual study participation which is latest 36 months after last patient in. The end of study will be at latest at 36 months after last patient in (LPI).

Study Type

Observational

Enrollment (Actual)

647

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79110
        • Praxis für interdisziplinäre Onkologie & Hämatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
low risk
Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
Drug: Panitumumab
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.
Other Names:
  • + FOLFIRI or FOLFOX
medium risk
Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
Drug: Panitumumab
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.
Other Names:
  • + FOLFIRI or FOLFOX
high risk
High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
Drug: Panitumumab
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.
Other Names:
  • + FOLFIRI or FOLFOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) of pre-defined risk groups low vs. high
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) of pre-defined risk groups low vs. intermediate
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
OS is defined as time from start of first line therapy to the date of death.
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
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
OS is defined as time from start of first line therapy to the date of death.
From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Overall Survival (OS)
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
OS is defined as time from start of first line therapy to the date of death.
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)
Time Frame: at 24 months
2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy.
at 24 months
Progression-free Survival (PFS)
Time Frame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
PFS is defined as time from start of first line therapy to first documentation of tumor progression or death due to any cause, whichever occurs first.
From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
12-months PFS Rate (12-mos PFSR)
Time Frame: at 12 months
2-yrs PFSR is defined as percentage of patients who are have not progressed or died due to any cause at 2 years after start of first line therapy.
at 12 months
Overall Response Rate (ORR)
Time Frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
ORR is defined as percentage of patients who achieve a partial or complete response as best response during the treatment period.
From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
Duration of Response (DoR)
Time Frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
DoR is defined as time from first documentation of any tumor response (≥ PR) until disease progression or death due to tumor progression.
From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
Primary and secondary resection of metastases
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Data on primary and/or secondary resections of liver or lung metastases will be collected.
From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Antineoplastic treatment in later lines
Time Frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Treatment sequences with duration will be documented.
From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported general and health-related quality of life ('VALIDATE PRO')
Time Frame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
Quality of life will be assessed with the EORTC QLQ-C30 and the EORTC Colorectal Modul QLQ-CR29 patient questionnaires during first line treatment and correlated with outcome.
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
Time Frame: From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)
Adverse Drug Reactions of Panitumumab
From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Collaborators

Amgen

Investigators

  • Principal Investigator: Norbert Marschner, Dr., Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Actual)

January 17, 2024

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimated)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-050341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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