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

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ClinicalTrials.gov Identifier: NCT03607656
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
RenJi Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
zhaoaiguang, Shanghai University of Traditional Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Drug: Oxaliplatin Drug: Capecitabine Other: TCM Phase 2 Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: TCM & Oxaliplatin & Capecitabine
Traditional Chinese Medicine oral taken twice a day for at least 3 months combined with intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21-28 days)
Drug: Oxaliplatin
Oxaliplatin powder injection

Drug: Capecitabine
Capecitabine tablet

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

Active Comparator: Oxaliplatin & Capecitabine
intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21-28 days
Drug: Oxaliplatin
Oxaliplatin powder injection

Drug: Capecitabine
Capecitabine tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607656


Contacts
Contact: Aiguang Zhao, M.D.,Ph.D 13661472241 2538312201@qq.com
Contact: Nida Cao, M.D. 13818949357 amandatsao77@163.com

Locations
China, Shanghai
Longhua Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Aiguang Zhao, M.D.,Ph D.    13661472241    2538312201@qq.com   
Contact: Nida Cao, M.D.    13818949357    amandatsao77@163.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
RenJi Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: Aiguang Zhao, M.D.,Ph.D Longhua Hospital Shanghai University of Traditional Chinese Medicine

Publications:
Responsible Party: zhaoaiguang, Principal Investigator, Clinical Professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03607656     History of Changes
Other Study ID Numbers: LONGHUA-2018-SH
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents