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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: DCF (docetaxel with cisplatin with 5-FU); Drug: DCS (docetaxel with cisplatin with TS-1)

Study type: Interventional

Funder types: Other

Identifiers

NCT01286766

4-2009-0332

Details and patient eligibility

About

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.

Full 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

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

DCS

Active Comparator group

Description:

DCS: docetaxel with cisplatin with TS-1

Treatment:

Drug: DCS (docetaxel with cisplatin with TS-1)

DCF

Active Comparator group

Description:

DCF : docetaxel with cisplatin with 5-FU

Treatment:

Drug: DCF (docetaxel with cisplatin with 5-FU)