drugset / Trial / NCT03607656
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer
Phase 2/3
Completed
270 enrolled
Shanghai University of Traditional Chinese Medicine
Jiangsu Province Hospital of Traditional Chinese Medicine · collabRenJi Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2018-06-08
- Primary completion
- 2022-10-31
- Completion
- 2023-11-30
Publications
- Background 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.
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Docetaxel | Small molecule | 40 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 40 mg/m2 | Oral |
| Background | fluorouracil | Small molecule | — | Intravenous |