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

Last updated: December 14, 2023
Sponsor: Shanghai University of Traditional Chinese Medicine
Overall Status: Completed

Phase

2/3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

S-1

TCM

Oxaliplatin

Clinical Study ID

NCT03607656
LONGHUA-2018-SH
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven gastric carcinoma with radical operation, TNM (primary tumor,regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American JointCommittee on Cancer [AJCC] gastric cancer staging）;
  • Karnofsky performance status higher than 70;
  • Adequate hepatic, renal, cardio and hematologic function;
  • With patients' consent and comply to long term follow-up.

Exclusion

Exclusion Criteria:

  • Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;
  • Histological type beyond gastric carcinoma;
  • Conversion chemotherapy before surgery;
  • Concurrent cancer;
  • Women of gravid or lactating; patients with mental illness;
  • Uncontrolled significant comorbid conditions.

Study Design

Total Participants: 270
Treatment Group(s): 6
Primary Treatment: S-1
Phase: 2/3
Study Start date:
June 08, 2018
Estimated Completion Date:
November 30, 2023

Study Description

The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized controlled trial.

Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.

Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.

Connect with a study center

  • Longhua Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

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