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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03043950
Other study ID # IOM-050341
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2017
Est. completion date January 17, 2024

Study information

Verified date April 2024
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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).


Recruitment information / eligibility

Status Completed
Enrollment 647
Est. completion date January 17, 2024
Est. primary completion date January 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Germany Praxis für interdisziplinäre Onkologie & Hämatologie Freiburg Baden-Württemberg

Sponsors (2)

Lead Sponsor Collaborator
iOMEDICO AG Amgen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient-reported general and health-related quality of life ('VALIDATE PRO') 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)
Other Adverse Drug Reactions 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)
Primary 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 Overall Survival (OS) of pre-defined risk groups low vs. intermediate 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)
Secondary Overall Survival (OS) of pre-defined risk groups intermediate vs. high 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)
Secondary Overall Survival (OS) 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)
Secondary 2-years OS Rate (2-yrs OSR) 2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy. at 24 months
Secondary Progression-free Survival (PFS) 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)
Secondary 12-months PFS Rate (12-mos PFSR) 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
Secondary Overall Response Rate (ORR) 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)
Secondary Duration of Response (DoR) 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)
Secondary Primary and secondary resection of metastases 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)
Secondary Antineoplastic treatment in later lines 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)
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