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)
- Registration Number
- NCT03043950
- Lead Sponsor
- iOMEDICO AG
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 647
- 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
- Any contraindication according to current SmPC
- Participation in other clinical trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description low risk Panitumumab Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) medium risk Panitumumab Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) high risk Panitumumab High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
- Primary Outcome Measures
Name Time Method Overall Survival (OS) of pre-defined risk groups low vs. high 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 Outcome Measures
Name Time Method Primary and secondary resection of metastases 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.
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) OS is defined as time from start of first line therapy to the date of death.
12-months PFS Rate (12-mos PFSR) 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.
Duration of Response (DoR) 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.
Antineoplastic treatment in later lines 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.
Overall Response Rate (ORR) 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.
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) OS is defined as time from start of first line therapy to the date of death.
Overall Survival (OS) 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-years OS Rate (2-yrs OSR) at 24 months 2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy.
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) 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.
Trial Locations
- Locations (1)
Praxis für interdisziplinäre Onkologie & Hämatologie
🇩🇪Freiburg, Baden-Württemberg, Germany