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

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastric Cancer Stage IIIB; Gastric Cancer Stage IIIC

Treatments: Drug: S-1; Drug: 5-FU; Other: TCM; Drug: Oxaliplatin; Drug: Docetaxel; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03607656

LONGHUA-2018-SH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

TCM combines CapOX/SOX/S-1+D/FLOT

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: 5-FU

Drug: S-1

Other: TCM

Drug: Oxaliplatin

Drug: Capecitabine

CapOX/SOX/S-1+D/FLOT

Active Comparator group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: 5-FU

Drug: S-1

Drug: Oxaliplatin

Drug: Capecitabine