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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

Phase 2
18 Years
70 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

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

Treatment scheme

- Screening period: D-21 to D1 (treatment day)

- Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT

- 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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

RECIST(Response Evaluation Criteria in Solid Tumors)

Outcome Description:

safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0) efficacy : tumor response is assessed every 2 cycles (6weeks) -> tumor response assessment(RECIST 1.0 version use)

Outcome Time Frame:

written in the description part below

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

September 2009

Completion Date:

August 2013

Related Keywords:

  • Gastric Cancer
  • unresectable
  • locally advanced
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms