MedTrace Logo

Perioperative Chemotherapy in Gastric Cancer

NCT04937738 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-11-06

No results posted yet for this study

Summary

Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

Conditions

Interventions

DRUG

Docetaxel

50mg/m2, d1, i.v., every 2 weeks

DRUG

Oxaliplatin

85 mg/m², d1, i.v., every 2 weeks

DRUG

Leucovorin

200 mg/m², d1, i.v., every 2 weeks

DRUG

Fluorouracil

2600 mg/m²d1 i.v. every 2 weeks

DRUG

Capecitabine

1000 mg/m² two times per day (BID), d1-14

DRUG

Oxaliplatin

130 mg/m² d1 i.v. every 3 weeks

Sponsors & Collaborators

  • Ukrainian Society of Clinical Oncology

    lead OTHER

Principal Investigators

  • Oleksii Dobrzhanskyi, MD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04937738 on ClinicalTrials.gov