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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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DCS (docetaxel with cisplatin with TS-1)
DCF (docetaxel with cisplatin with 5-FU)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring unresectable, locally advanced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DCS

DCF

Arm Description

DCS: docetaxel with cisplatin with TS-1

DCF : docetaxel with cisplatin with 5-FU

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 27, 2011
Last Updated
March 4, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01286766
Brief Title
Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
unresectable, locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCS
Arm Type
Active Comparator
Arm Description
DCS: docetaxel with cisplatin with TS-1
Arm Title
DCF
Arm Type
Active Comparator
Arm Description
DCF : docetaxel with cisplatin with 5-FU
Intervention Type
Drug
Intervention Name(s)
DCS (docetaxel with cisplatin with TS-1)
Other Intervention Name(s)
Taxotere, CDDP, TS-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
DCF (docetaxel with cisplatin with 5-FU)
Other Intervention Name(s)
5-FU, Taxotere, CDDP
Intervention Description
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
Primary Outcome Measure Information:
Title
RECIST(Response Evaluation Criteria in Solid Tumors)
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<Response Evaluation Criteria in Solid Tumor> 1.0 version use)
Time Frame
written in the description part below

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-750
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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