Metronomic Capecitabine in Stage III Gastric Cancer

July 4, 2024 updated by: Dazhi Xu, Fudan University

Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial

The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

722

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
  2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
  3. R0 gastrectomy with D2 lymphadenectomy
  4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion Criteria:

  1. History of chemotherapy, radiotherapy, immunotherapy or target therapy
  2. Multiple primary tumors
  3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  4. Unavailable for R0 resection and D2 lymph node dissection.
  5. Patients with stage IV gastric cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard therapy group
Observation after completion of standard adjuvant chemotherapy,
Other: Observation
observation
Experimental: Metronomic capecitabine
Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
Drug: Metronomic capecitabine group
500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3-year
DFS
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3-year
OS
3-year
Side effects
Time Frame: 1-year
Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Estimated)

March 10, 2029

Study Completion (Estimated)

March 10, 2029

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meca-GC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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