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Panitumumab

Antineoplastic Agents, Immunological

Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

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.

Norbert Marschner, Dr.

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)

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).

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 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)

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.

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.

OS is defined as time from start of first line therapy to the date of death.

2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy.

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.

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.

ORR is defined as percentage of patients who achieve a partial or complete response as best response during the treatment period.

DoR is defined as time from first documentation of any tumor response (≥ PR) until disease progression or death due to tumor progression.

Data on primary and/or secondary resections of liver or lung metastases will be collected.

Treatment sequences with duration will be documented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT03043950	Metastatic Colo... RAS Wild-type	Panitumumab	18 Years -	iOMEDICO AG
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)	NCT03043950	Metastatic Colo... RAS Wild-type	Panitumumab	18 Years -	iOMEDICO AG

Spots Global Cancer Trial Database for mccs prognostic score