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

March 4, 2014 updated by: Yonsei University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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)
  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:
  • 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)
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)
written in the description part below

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (ESTIMATE)

January 31, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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