Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer

NCT02142322 | Completed Phase 2

• 1 other identifier: H-0406-127-007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• response rate

  response rate by the RECIST criteria

  22 weeks

Secondary Outcomes (4)

• Grade 3-4 toxicity

  one year

• median overall survival

  1 year

• median time to treatment failure

  1 year

• resection rate

  1 year

Study Arms (1)

Modified FOLFOX6

EXPERIMENTAL

Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.

Drug: MODIFIED FOLFOX6

Interventions

MODIFIED FOLFOX6 DRUG

Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.

Modified FOLFOX6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis are eligible for this study (clinical stage: cT2-4 and N+). At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0) \[17\] is required. Other eligibility criteria include age between 18 and 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, no prior chemotherapy or radiotherapy, and adequate bone marrow, hepatic and renal function (absolute neutrophil count \[ANC\] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal \[ULN\], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Seock-Ah Im, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: May 20, 2014
• Study Start: June 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 17, 2025

Record last verified: 2014-05

Locations

KR (2)