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NCT06313567RecruitingPhase 3

Metronomic Capecitabine in Stage III Gastric Cancer

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

Source: ClinicalTrials.gov · Last updated 8 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
722 (estimated)
First submitted
10 Mar 2024
Start date
10 Mar 2024
Primary completion date
10 Mar 2029
Lead sponsor
Fudan University
NCT number
NCT06313567

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 722
  • From 10 Mar 2024 to the primary completion date, 10 Mar 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unavailable for R0 resection and D2 lymph node dissection.

Other illness

  • History of chemotherapy, radiotherapy, immunotherapy or target therapy
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  • Patients with stage IV gastric cancer

Other

  • Multiple primary tumors

Who the study is looking for

  • 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).

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.