Gastric Cancer Stage IIIB, Gastric Cancer Stage IIIC
Conditions
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.
Interventions
DRUGOxaliplatin
Oxaliplatin powder injection
DRUGCapecitabine
Capecitabine tablet
OTHERTCM
TCM decoction orally taken twice a day for at least 3 months
DRUGS-1
S-1 capsule
DRUGDocetaxel
Docetaxel injection
DRUG5-FU
5-FU injection
Sponsors
RenJi Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease Free Survival rate | 36 months | The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 scale | 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). |
| Safety （adverse effects） | 36 months | Using NCI-CTC standard to record adverse effects of chemotherapy and treatments. |
Countries
China
Outcome results
None listed