Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

524

Participants

Timeline

Start Date

January 13, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2028

Conditions
Gastric CancerChemotherapy Effect
Interventions
DRUG

Chemotherapy drug

The preoperative SOX chemotherapy consists of three-week cycles of intravenously administered oxaliplatin 130 mg/m2 on day 1 and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): 40mg BID for BSA \< 1.25 m2; 50mg BID for 1.25 m2 \< BSA \<1.5 m2; 60mg BID for BSA \> 1.5 m2. Day 15 to day 21 is the rest period.

PROCEDURE

Gastrectomy

Surgery is planned 3-4 weeks after the last cycle of chemotherapy. A standard D2 radical laparoscopic gastrectomy is recommended. The extent of gastric resection and lymphadenectomy were performed as per the treatment guidelines. Reconstruction after gastrectomy was decided by the surgeon. All operations are performed by well trained and experienced surgical team to guarantee the quality of surgery, including harvesting more than 16 lymph nodes.

PROCEDURE

Laparoscopic exploration

Laparoscopic exploration is to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum according to the standard acquirements reported before. Patients with any patterns of distant metastases, suggestive of distant metastasis (M1), will be excluded from the trial.

Trial Locations (1)

100853

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER