Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Chest Wall: A Phase II Trial

UMIN ID: UMIN000001810

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 53
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive chemotherapy consisted of Cisplatin 80 mg/m2 day 1 + Vinorelbine 20 mg/m2 days 1 and 8 / 4 weeks x 2 courses Patients receive also concurrent radiotherapy (Radiation field: Primary tumor, Total dose 40 Gy (2 Gy/day for 4 weeks)). At 3 to 6 weeks after completion of induction therapy, patients undergo surgical resection (lobectomy or pneumonectomy with mediastinal lymph node dissection combined with chest wall resection).

Outcome(s)

• Primary Outcome: Three-year survival
• Secondary Outcome: Completion rate and objective response rate of induction chemoradiotherapy, Adverse effects of induction chemoradiotherapy, Operability after induction chemoradiotherapy, Complete resection rate, Perioperative morbidity and mortality, Pathologic response, Recurrence patterns, Disease free survival, and Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1.N2 disease: Obvious N2 disease at CT/PET, or histologically and/or cytologically confirmed N2 disease by mediastinoscopy and/or EBUS. 2.Active double cancer 3.Prior chemotherapy or radiotherapy 4.Patients with serious comobidities; serious cardiac complications such as uncontrollable angina, myocardial infarction within 3 months, heart failure, arrhythmia required treatment, uncontrollable diabetes mellitus and hypertion, definite interstitial pneumonina, lung fibrosis, and severe emphysema at CT, and infectious diseases. 5.Pregnant or nursing woman 6.V20 more than 30% of normal lung

Related Information

• Primary Sponsor: Central Japan Lung Study Group
• Source(s) of Monetary Support: None