Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06313567

Metronomic Capecitabine in Stage III Gastric Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Dazhi Xu, MD,PHD

CONTACT

[email protected]

021-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
  • Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
  • R0 gastrectomy with D2 lymphadenectomy
  • ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  • 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

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

Treatment and study plan

Metronomic capecitabine group

Drug

500 mg/m2 body surface area twice daily for 1 year; metronomic capecitabine group

observation

Other

observation

Primary outcomes

  1. Disease-free survival

    Time frame: 3-year

    DFS

Secondary outcomes

  1. Overall survival

    Time frame: 3-year

    OS

  2. Side effects

    Time frame: 1-year

    Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Guo, MD

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 15, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.