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

Gastric Cancer Clinical Trial

Official title: A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

• NCT number: NCT01286766
• Study type: Interventional
• Source: Yonsei University
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Completion date: June 2012