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Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection

NCT03817268 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2020-04-20

No results posted yet for this study

Summary

Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that \~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected \>T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.

Conditions

Interventions

DRUG

Capecitabine monotherapy

Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2026-01-16
Completion
2026-01-30

Countries

  • China

Study Locations

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Entities

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 NCT03817268 on ClinicalTrials.gov