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Completed

NCT Number: NCT01286766

Neoadjuvant Combination Chemotherapy of DCS and DCF 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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, 120-750, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCS (docetaxel with cisplatin with TS-1)

Drug
  • 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

DCF (docetaxel with cisplatin with 5-FU)

Drug
  • 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: 5-FU, Taxotere, CDDP

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2011
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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