Clinical trial 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)
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
RAS Wild-type
Keywords: mCRC
First line
Panitumumab
mCCS Prognostic Score
Prognosis
Ras wild type
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2017-02-06
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS) of pre-defined risk groups low vs. high
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Secondary outcomes:
measure: Overall Survival (OS) of pre-defined risk groups low vs. intermediate
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
measure: Overall Survival (OS) of pre-defined risk groups intermediate vs. high
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
measure: Overall Survival (OS)
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
measure: 2-years OS Rate (2-yrs OSR)
timeFrame: at 24 months
measure: Progression-free Survival (PFS)
timeFrame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
measure: 12-months PFS Rate (12-mos PFSR)
timeFrame: at 12 months
measure: Overall Response Rate (ORR)
timeFrame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
measure: Duration of Response (DoR)
timeFrame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
measure: Primary and secondary resection of metastases
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
measure: Antineoplastic treatment in later lines
timeFrame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Other outcomes:
measure: Patient-reported general and health-related quality of life ('VALIDATE PRO')
timeFrame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
measure: Adverse Drug Reactions
timeFrame: From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)
Locations:
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie
state: Baden-Württemberg
Study officials:
affiliation: Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek
name: Norbert Marschner, Dr.
role: PRINCIPAL_INVESTIGATOR
References: