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

NCT01286766 | Completed Phase 2 DMC

• 1 other identifier: 4-2009-0332
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

unresectable; locally advanced

Outcome Measures

Primary Outcomes (1)

• 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\<Response Evaluation Criteria in Solid Tumor\> 1.0 version use)

  written in the description part below

Study Arms (2)

DCS

ACTIVE COMPARATOR

DCS: docetaxel with cisplatin with TS-1

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

DCF

ACTIVE COMPARATOR

DCF : docetaxel with cisplatin with 5-FU

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

Interventions

DCS (docetaxel with cisplatin with TS-1) 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.

Also known as: Taxotere, CDDP, TS-1

DCS

DCF (docetaxel with cisplatin with 5-FU) 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

Also known as: 5-FU, Taxotere, CDDP

DCF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-750, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cycloserine; Docetaxel; Cisplatin; titanium silicide; Pentostatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

KR (1)