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Study Complete
Sponsor ID
20120286

Prospective observational study of 1st and 2nd line Vectibix® use in RAS-wt mCRC pts to evaluate pattern of use and ORRVISION

Sponsor ID
20120286
Clinicaltrials.gov ID
NCT02322736
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.

Additional Study Details

Phase
Phase 4
Product
panitumumab
Type
Observational
Masking
N/A
Enrollment
218
Additional Study Details

Protocol Summary

Primary Outcome Measures

To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.

Timeframe: 42 months

Secondary Outcome Measures

To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.

Timeframe: 42 months

Locations

Location
Status
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Location
Research Site
Thessaloniki, Greece, 54622
Status
Recruiting
Location
Research Site
Athens, Greece, 14564
Status
Recruiting
Location
Research Site
Athens, Greece, 11527
Status
Recruiting
Location
Research Site
Nea Kifissia, Athens, Greece, 14564
Status
Recruiting
Location
Research Site
Athens, Greece, 15562
Status
Recruiting
Location
Research Site
Athens, Greece, 11522
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Nov 2014 - Aug 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    •Adult patient (age ≥18 years) at enrollment •Histological documentation of mCRC diagnosis •RAS WT tumor documented before study enrolment as per routine laboratory finding •Subjects whose care will be managed primarily by the enrolling physician and/or all records will be available •Measurable disease at baseline (preferably according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used) •Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including Vectibix® as per indication •Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion •Signed informed consent
    Exclusion Criteria:
    •Participation in any interventional clinical study (currently or during the three previous months from enrollment). •Compromised ability to give informed consent (defined per clinical judgment). •Unknown or mutant RAS tumor type