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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Histologically/cytologically confirmed gastric adenocarcinoma

• Age 18 to 70 years old

• ECOG performance Status 0~1

• Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA~IV), M0, P0, H0, CY0

• No pretreatment (radiotherapy or chemotherapy) for gastric cancer

• Adequate organ function

• Hb ≥ 9.0 g/dL

• WBC ≥ 4,000/µL

• ANC ≥ 2,000/µL (*ANC = Neutrophil segs ＋ Neutrophil bands)

• Platelet ≥ 100 × 103/ µL

• Total bilirubin: ≤ 1.5 × UNL

• CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)

• AST/ALT, ALP: ≤ 2.5 × UNL

• Written informed consent

Exclusion Criteria:

• Distant metastasis on diagnosis

• cT1-2

• Cancer of gastroesophageal junction (GEJ)

• Poor oral intake or absorption deficiency syndrome

• Gastric outlet obstruction, perforation or bleeding

• Medically uncontrollable chronic illness or infection

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• History of clinically significant cardiac disease

• Past or concurrent history of neoplasm last < 5 year other than gastric cancer

• Prior gastrectomized patients

• Concomitant administration of any other experimental drug under investigation

• Peripheral neuropathy ≥ NCI-CTC grade 2