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The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

NCT03607656 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-12-18

No results posted yet for this study

Summary

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

Conditions

  • Gastric Cancer Stage IIIB
  • Gastric Cancer Stage IIIC

Interventions

DRUG

Oxaliplatin

Oxaliplatin powder injection

DRUG

Capecitabine

Capecitabine tablet

OTHER

TCM

TCM decoction orally taken twice a day for at least 3 months

DRUG

S-1

S-1 capsule

DRUG

Docetaxel

Docetaxel injection

DRUG

5-FU

5-FU injection

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Aiguang Zhao, M.D.,Ph.D · Shanghai University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-10-31
Completion
2023-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03607656 on ClinicalTrials.gov