Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: DCS (docetaxel with cisplatin with TS-1); Drug: DCF (docetaxel with cisplatin with 5-FU)

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-750
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DCS; DCS: docetaxel with cisplatin with TS-1	Drug: DCS (docetaxel with cisplatin with TS-1); S-1: 70 mg/m2 #2 bid PO, D1-14; Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8; Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks.; Other Names: Taxotere; CDDP; TS-1
Active Comparator: DCF; DCF : docetaxel with cisplatin with 5-FU	Drug: DCF (docetaxel with cisplatin with 5-FU); 5-FU: 1,000 mg/m2 CI, D1-3; Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by; Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks.Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia)treatment is repeated until 4 cycles; Other Names: Taxotere; CDDP; 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RECIST(Response Evaluation Criteria in Solid Tumors)	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<Response Evaluation Criteria in Solid Tumor> 1.0 version use)	written in the description part below

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimated): January 31, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: unresectable; locally advanced
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: 4-2009-0332

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No