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

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ClinicalTrials.gov Identifier: NCT01286766
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: DCS (docetaxel with cisplatin with TS-1) Drug: DCF (docetaxel with cisplatin with 5-FU) Phase 2

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  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: DCS
DCS: docetaxel with cisplatin with TS-1
Drug: DCS (docetaxel with cisplatin with TS-1)
  1. S-1: 70 mg/m2 #2 bid PO, D1-14
  2. Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8
  3. 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)
  1. 5-FU: 1,000 mg/m2 CI, D1-3
  2. Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by
  3. 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:
  • 5-FU
  • Taxotere
  • CDDP



Primary Outcome Measures :
  1. RECIST(Response Evaluation Criteria in Solid Tumors) [ Time Frame: written in the description part below ]
    • 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286766


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-750
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01286766     History of Changes
Other Study ID Numbers: 4-2009-0332
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Yonsei University:
unresectable
locally advanced

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs