FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Color… (NCT03142516) | Clinical Trial Compass
CompletedPhase 2
FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status
Spain20 participantsStarted 2017-10-31
Plain-language summary
To estimate progression-free survival at one year in elderly patients with RAS/BRAF wild-type unresectable mCRC and good performance status treated with FOLFIRI + panitumumab as first-line therapy.
The clinical hypothesis of this study is that the combination of panitumumab and FOLFIRI is a good treatment option in elderly patients with good performance status and RAS/BRAF wild-type unresectable mCRC. Another purpose of this clinical trial is to determine the RAS/BRAF mutation status in liquid biopsies at baseline and at the time of disease progression.
Who can participate
Age range70 Years
SexALL
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Inclusion criteria
✓. Males or females ≥ 70 years,
✓. Able to understand, sign and date an informed consent form approved by the IEC,
✓. Histologically confirmed colorectal carcinoma with metastatic disease,
✓. RAS/BRAF wild-type status in solid biopsy confirmed prior to inclusion of the study,
✓. No previous treatment for metastatic disease,
✓. Patients starting therapy with FOLFIRI + panitumumab with a treatment aim other than achieving potential resectability of the disease,
✓. Independence in activities of daily living (ADL) based on the Katz Index and in instrumental activities of daily living (IAL) based on the Lawton Index,
✓. Having no or only one comorbidity according to the Charlson Comorbidity Index. The following ones are not considered comorbidities as long as it is provided they are adequately controlled with medication: gastroduodenal ulcer, diabetes without target organs' damage, chronic respiratory disease and connective tissue disease.
Exclusion criteria
What they're measuring
1
Progression-free survival at one year
Timeframe: 12 months after inclusion
Trial details
NCT IDNCT03142516
SponsorGrupo Espanol Multidisciplinario del Cancer Digestivo
✕. Diagnosed or suspected central nervous system (CNS) metastasis,
✕. Patients with initially resectable metastases at the time of diagnosis of metastatic disease.
✕. History or presence of another malignancy, with the exception of curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer or any curatively treated solid tumour, with no active disease or administration of treatment within 5 years prior to inclusion in the study,
✕. Prior treatment with irinotecan,
✕. Prior adjuvant chemotherapy for colorectal cancer terminated less than 6 months before metastatic disease was diagnosed,
✕. Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, cetuximab), anti- vascular endothelial growth factor (VEGF) or treatment with small molecule EGFR inhibitors (eg, erlotinib),
✕. Unresolved toxicities from prior systemic treatment that, in the investigator's opinion, make the patient unsuitable for inclusion,
✕. Hormone therapy, immunotherapy with experimental or approved antibodies/proteins (e.g. bevacizumab) ≤ 30 days prior to inclusion,