Metronomic Capecitabine in Stage III Gastric Cancer

NCT ID: NCT06313567

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2029-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metronomic capecitabine

Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,

Group Type EXPERIMENTAL

Metronomic capecitabine group

Intervention Type DRUG

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

Standard therapy group

Observation after completion of standard adjuvant chemotherapy,

Group Type ACTIVE_COMPARATOR

Observation

Intervention Type OTHER

observation

Interventions

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Metronomic capecitabine group

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

Intervention Type DRUG

Observation

observation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Dazhi Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Guo, MD

Role: CONTACT

021-64175590

Facility Contacts

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Dazhi Xu, MD,PHD

Role: primary

021-64175590

Other Identifiers

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Meca-GC

Identifier Type: -

Identifier Source: org_study_id

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