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

Gastric Cancer Stage IIIB Clinical Trial

— CHANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607656
• Other study ID #: LONGHUA-2018-SH
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 8, 2018
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?b and ?c;

• Histological type beyond gastric carcinoma;

• Conversion chemotherapy before surgery;

• Concurrent cancer;

• Women of gravid or lactating; patients with mental illness;

• Uncontrolled significant comorbid conditions.

Related Conditions & MeSH terms

• Gastric Cancer Stage IIIB
• Gastric Cancer Stage IIIC
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
Oxaliplatin powder injection
• Capecitabine
Capecitabine tablet

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

Drug:
• S-1
S-1 capsule
• Docetaxel
Docetaxel injection
• 5-FU
5-FU injection

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Jiangsu Province Hospital of Traditional Chinese Medicine, RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7. — View Citation

Xu Y, Zhao AG, Li ZY, Zhao G, Cai Y, Zhu XH, Cao ND, Yang JK, Zheng J, Gu Y, Han YY, Zhu YJ, Yang JZ, Gao F, Wang Q. Survival benefit of traditional Chinese herbal medicine (a herbal formula for invigorating spleen) for patients with advanced gastric cancer. Integr Cancer Ther. 2013 Sep;12(5):414-22. doi: 10.1177/1534735412450512. Epub 2012 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Disease Free Survival rate	The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization.	36 months
Secondary	Safety (adverse effects)	Using NCI-CTC standard to record adverse effects of chemotherapy and treatments.	36 months
Secondary	EORTC QLQ-C30 scale	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).	36 months