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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer Stage IIIB, Gastric Cancer Stage IIIC

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Capecitabine
* Other: TCM
* Drug: S-1
* Drug: Docetaxel
* Drug: 5-FU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM combines CapOX/SOX/S-1+D/FLOT<br>Traditional Chinese Medicine oral taken twice a day for at least 3 months combined with chemotherapy. The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy. | Drug: Oxaliplatin<br>* Oxaliplatin powder injection<br>Drug: Capecitabine<br>* Capecitabine tablet<br>Other: TCM<br>* TCM decoction orally taken twice a day for at least 3 months<br>Drug: S-1<br>* S-1 capsule<br>Drug: Docetaxel<br>* Docetaxel injection<br>Drug: 5-FU<br>* 5-FU injection<br>|
| Active Comparator: CapOX/SOX/S-1+D/FLOT<br>The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy. | Drug: Oxaliplatin<br>* Oxaliplatin powder injection<br>Drug: Capecitabine<br>* Capecitabine tablet<br>Drug: S-1<br>* S-1 capsule<br>Drug: Docetaxel<br>* Docetaxel injection<br>Drug: 5-FU<br>* 5-FU injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety （adverse effects） | Using NCI-CTC standard to record adverse effects of chemotherapy and treatments. | 36 months | 
| 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 |