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Completed

NCT Number: NCT01851941

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

The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.

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Key information

Conditions

Advanced Gastric Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis (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)
  • age between 18 and 75 years
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • no prior chemotherapy or radiotherapy
  • 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).

Exclusion criteria

  • 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
  • other serious diseases

Treatment and study plan

mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )

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, which is 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.

Primary outcomes

  1. clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy

    Time frame: 4 cycles of chemotherapy (expected average of 8 weeks)

Secondary outcomes

  1. Time to progression

    Time frame: From date of study enrollment until the date of first documented progression, assessed up to 60 months

  2. overall survival

    Time frame: From date of study enrollment until the date of first documented progression, assessed up to 60 months

Other outcomes

  1. gene expression profile

    Time frame: after 4 cycles of chemotherapy (expected average of 8 weeks)

  2. early metabolic response by PET-CT

    Time frame: 2 cycles of chemotherapy (expected average of 4 weeks)

  3. Pharmacologic Genetic Marker

    Time frame: 4 cycles of chemotherapy (expected average of 8 weeks)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
First posted
May 13, 2013
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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