Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
Elderly patients are generally underrepresented in the study populations of combination
chemotherapy trials. In gastric cancer patients, oxaliplatin has shown a more favorable
toxicity profile than cisplatin. A combination chemotherapy of 5-fluorouracil (5-FU) with
oxaliplatin, mainly FOLFOX regimens, has been investigated in numerous phase II studies,
using different doses and schedules, and has shown considerable antitumor activity. Insofar
as toxicity is concerned, significant toxicities, including myelo-suppression and peripheral
neuropathy, are a major issue for elderly patients. A modified FOLFOX regimen by omitting the
administration of bolus 5-fluorouracil have shown a good profile of activity and tolerability
in the elder population. This study evaluates the efficacy and safety of a modified FOLFOX (m
FOLFOX) regimen for up to 8 cycles followed by capecitabine maintenance in elderly patients
with metastatic gastric cancer and presenting associated disease(s)