Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

Official title:

A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142322
• Other study ID #: H-0406-127-007
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2011
• Last updated: May 15, 2014
• Start date: June 2004
• Est. completion date: June 2011

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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] = 1.5?109/L, platelet count = 100?109/L, total bilirubin = 1.5?upper limit of normal [ULN], serum transaminases = 2.5?ULN, alkaline phosphatase = 2.5?ULN, serum creatinine = 1.5?ULN or actual or calculated creatinine clearance = 50 mL/min).

Exclusion Criteria:

• Exclusion criteria include clinical stage T1 tumors, clinical or radiologic evidence of distant metastasis, intestinal obstruction or impending obstruction, active tumor bleeding, interstitial pneumonitis or symptomatic pulmonary fibrosis, peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade =1, pregnant or breastfeeding patients, and other serious diseases.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• MODIFIED FOLFOX6
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	response rate by the RECIST criteria	22 weeks	No
Secondary	toxicity	toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0	one year	Yes
Secondary	median overall survival	median value of the time from enrollment to the patient's death	1 year	No
Secondary	median time to treatment failure	median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity	1 year	No
Secondary	resection rate	the rate of patients whose tumor was completely resected	1 year	No