Skip to main content
OpenTrials
Completed

NCT Number: NCT03607656

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Stage IIIB Digestive System Diseases Digestive System Neoplasms Gastric Cancer Stage IIIC Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee 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 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.

Treatment and study plan

Oxaliplatin

Drug

Oxaliplatin powder injection

Capecitabine

Drug

Capecitabine tablet

TCM

Other

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

S-1

Drug

S-1 capsule

docetaxel

Drug

Docetaxel injection

5-FU

Drug

5-FU injection

Primary outcomes

  1. 3-year Disease Free Survival rate

    Time frame: 36 months

    The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization.

Secondary outcomes

  1. Safety （adverse effects）

    Time frame: 36 months

    Using NCI-CTC standard to record adverse effects of chemotherapy and treatments.

  2. EORTC QLQ-C30 scale

    Time frame: 36 months

    Using the EORTC QLQ-C30 scale (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30) to evaluate the quality of life of patients. The scale includes 14 aspects: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial problem, with each aspect scores from one point to four points (lower points represent a better quality of life), and a general quality of life scores from one point to seven points (higher points represent a better quality of life).

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine
  • RenJi Hospital

Registry information

Official study title

The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial

Acronym: CHANGE

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 31, 2018
Registry last updated
Dec 18, 2023

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.

Related clinical trials

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