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)

Sponsor

iOMEDICO AG (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03043950

Collaborator

Amgen (Industry)

647

Enrollment

Location

85.2

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer RAS Wild-type	Drug: Panitumumab

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).

Study Design

Study Type:

Observational

Actual Enrollment :

647 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jan 25, 2017

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
low risk Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)	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. Other Names: + FOLFIRI or FOLFOX
medium risk Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)	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. Other Names: + FOLFIRI or FOLFOX
high risk High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)	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. Other Names: + FOLFIRI or FOLFOX

Arm

Intervention/Treatment

low risk

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

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.

Other Names:

+ FOLFIRI or FOLFOX

medium risk

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

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.

Other Names:

+ FOLFIRI or FOLFOX

high risk

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

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.

Other Names:

+ FOLFIRI or FOLFOX

Outcome Measures

Primary Outcome Measures

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

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) 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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Patient-reported general and health-related quality of life ('VALIDATE PRO') [From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)]
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.
Adverse Drug Reactions [From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)]
Adverse Drug Reactions of Panitumumab