Metastatic Colorectal Cancer Clinical Trial
— VALIDATEOfficial 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)
Verified date | April 2024 |
Source | iOMEDICO AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG | Amgen |
Germany,
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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