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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

270

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2018

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.5 years study duration

Study Start

First participant enrolled

June 8, 2018

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed

Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4.4 years

First QC Date

July 1, 2018

Last Update Submit

December 14, 2023

Conditions

Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Safety （adverse effects）
36 months
EORTC QLQ-C30 scale
36 months

Study Arms (2)

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

EXPERIMENTAL

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: OxaliplatinDrug: CapecitabineOther: TCMDrug: S-1Drug: DocetaxelDrug: 5-FU

CapOX/SOX/S-1+D/FLOT

ACTIVE COMPARATOR

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: OxaliplatinDrug: CapecitabineDrug: S-1Drug: DocetaxelDrug: 5-FU