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

Gastric Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286766
• Other study ID #: 4-2009-0332
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2011
• Last updated: March 4, 2014
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Drug:
• DCS (docetaxel with cisplatin with TS-1)
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.
• DCF (docetaxel with cisplatin with 5-FU)
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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RECIST(Response Evaluation Criteria in Solid Tumors)	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	written in the description part below	No