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Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer

NCT02002195 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2019-02-27

No results posted yet for this study

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)

Conditions

  • Metastatic Gastric Cancer

Interventions

DRUG

FOLFOX

Oxaliplatin 85 mg/m2 is given as a 2 hours intravenous infusion, concomitant to and S-leucovorin 200 mg/m2, and followed by 5-FU 2,400 mg/m2 as a 46 hours continuous infusion.

DRUG

Capecitabine

Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.

Sponsors & Collaborators

  • International Group of Endovascular Oncology

    lead OTHER

Principal Investigators

  • Vincenzo Catalano, MD · AORMN, U.O.C. Oncologia, Ospedale San Salvatore

Eligibility

Min Age
65 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2021-11-30
Completion
2022-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02002195 on ClinicalTrials.gov