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

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: DCS (docetaxel with cisplatin with TS-1); Drug: DCF (docetaxel with cisplatin with 5-FU)

• Registration Number: NCT01286766
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCS	DCS (docetaxel with cisplatin with TS-1)	DCS: docetaxel with cisplatin with TS-1
DCF	DCF (docetaxel with cisplatin with 5-FU)	DCF : docetaxel with cisplatin with 5-FU

Primary Outcome Measures

Name	Time	Method
RECIST(Response Evaluation Criteria in Solid Tumors)	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)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of