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
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC||Drug: Oxaliplatin Drug: Capecitabine Other: TCM||Phase 2 Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
Oxaliplatin powder injection
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
Oxaliplatin powder injection
- 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.
- Safety （adverse effects） [ Time Frame: 36 months ]Using NCI-CTC standard to record adverse effects of chemotherapy and treatments.
- 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).
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
|Contact: Aiguang Zhao, M.D.,Ph.Dfirstname.lastname@example.org|
|Contact: Nida Cao, M.D.||email@example.com|
|Shanghai, Shanghai, China, 200032|
|Contact: Aiguang Zhao, M.D.,Ph D. 13661472241 firstname.lastname@example.org|
|Contact: Nida Cao, M.D. 13818949357 email@example.com|
|Principal Investigator:||Aiguang Zhao, M.D.,Ph.D||Longhua Hospital Shanghai University of Traditional Chinese Medicine|