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

NCT ID: NCT01286766

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

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

Conditions

Gastric Cancer

Keywords

unresectable; locally advanced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCS

DCS: docetaxel with cisplatin with TS-1

Group Type: ACTIVE_COMPARATOR

DCS (docetaxel with cisplatin with TS-1)

Intervention Type: DRUG

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.

DCF

DCF : docetaxel with cisplatin with 5-FU

Group Type: ACTIVE_COMPARATOR

DCF (docetaxel with cisplatin with 5-FU)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Taxotere; CDDP; TS-1; 5-FU; Taxotere; CDDP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2009-0332

Identifier Type: -

Identifier Source: org_study_id