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Completed

NCT Number: NCT03043950

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)

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)

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site RAS Wild-type Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panitumumab

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Other outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Amgen

Registry information

Official study title

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)

Acronym: VALIDATE

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2017
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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