Spots Global Cancer Trial Database for Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma

Study Description

Brief Summary: Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.

Detailed Description: Treatment scheme * Screening period: D-21 to D1 (treatment day) * Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan. * Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998) * Tumor response is assessed every 2 cycles (6 weeks) * Treatment is repeated until,. * 4 cycles * progressive disease * unacceptable toxicity * patient's withdrawal * Gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy * Gastric surgery is for curative aim and should include ≥ D2 LN dissection. * Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin. * Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy. * Follow up for survival is repeated every 3 months for 2 years Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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