Clinical trial NCT03607656: The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer
Official title: The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer Stage IIIB
Gastric Cancer Stage IIIC
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2018-07-31
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: 3-year Disease Free Survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Safety （adverse effects）
timeFrame: 36 months
measure: EORTC QLQ-C30 scale
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Aiguang Zhao, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Li Z, Zhang G, Cao N, Xu J, Dong J, Li J, Zhu X, Xu Y, Han C, Wang R, Xia X, Zhao G, Huan X, Fan J, Zhao A. Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial. Trials. 2022 Jan 21;23(1):68. doi: 10.1186/s13063-022-06013-5.