Metastatic Colorectal CancerVALIDATENCT03043950
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)
An observational study of Metastatic Colorectal Cancer and RAS Wild-type, run by iOMEDICO AG at 1 site in Germany.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, RAS Wild-type
- What is being tested?
- Panitumumab
- Type of treatment
- Injection or infusion
- How many people
- 647 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2017to 17 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with RAS-WT mCRC scheduled for the treatment with panitumumab and FOLFIRI or FOLFOX who have not received any prior systemic antineoplastic therapy in the palliative setting.
Who may be able to join
- 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
Who cannot join
- Any contraindication according to current SmPC
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Baden-Wurttemberg, 79110
About this study
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)
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)
Read the 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).
- Conditions
- Metastatic Colorectal Cancer, RAS Wild-type
- Being tested
- Panitumumab
- Keywords
- mCRC, First line, Panitumumab, mCCS Prognostic Score, Prognosis, Ras wild type
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called + FOLFIRI or FOLFOX
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.
| Study group | Role | What they receive |
|---|---|---|
| low risk | Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) Receives: Drug: Panitumumab | |
| medium risk | Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) Receives: Drug: Panitumumab | |
| high risk | High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) Receives: Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Secondary outcomes (10)
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.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
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.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Overall Survival (OS)
OS is defined as time from start of first line therapy to the date of death.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
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.
Measured: at 24 months
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.
Measured: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
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.
Measured: at 12 months
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.
Measured: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
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.
Measured: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
Primary and secondary resection of metastases
Data on primary and/or secondary resections of liver or lung metastases will be collected.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Antineoplastic treatment in later lines
Treatment sequences with duration will be documented.
Measured: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start25 Jan 2017
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Norbert Marschner, Dr., Principal investigator, Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043950
- Sponsor's protocol ID
- IOM-050341
- Acronym
- VALIDATE
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2017
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03043950
- Acronym / sponsor ID
- VALIDATE / IOM-050341
- Conditions
- Metastatic Colorectal Cancer, RAS Wild-type
- Keywords
- mCRC, First line, Panitumumab, mCCS Prognostic Score, Prognosis, Ras wild type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low risk | – | Drug: PanitumumabLow risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) |
| medium risk | – | Drug: PanitumumabMedium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) |
| high risk | – | Drug: PanitumumabHigh risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with RAS-WT mCRC scheduled for the treatment with panitumumab and FOLFIRI or FOLFOX who have not received any prior systemic antineoplastic therapy in the palliative setting.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Any contraindication according to current SmPC
- Participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanitumumabAlso: + FOLFIRI or FOLFOXPatients 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. | Drug | high risk, low risk, medium risk |
Primary outcome
Overall Survival (OS) of pre-defined risk groups low vs. high
Time frame: 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.
10 secondary outcomes
Overall Survival (OS) of pre-defined risk groups low vs. intermediate
Time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Overall Survival (OS) of pre-defined risk groups intermediate vs. high
Time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Overall Survival (OS)
Time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
2-years OS Rate (2-yrs OSR)
Time frame: at 24 months
Progression-free Survival (PFS)
Time frame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
12-months PFS Rate (12-mos PFSR)
Time frame: at 12 months
Overall Response Rate (ORR)
Time frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
Duration of Response (DoR)
Time frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
Primary and secondary resection of metastases
Time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Antineoplastic treatment in later lines
Time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Marschner, Dr. principal investigator
Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and RAS Wild-type, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) of pre-defined risk groups low vs. high (time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.