NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000174

Registered date:14/09/2005

A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPathologically confirmed stage IIIA-N2 non-small cell lung cancer
Date of first enrollment2001/01/01
Target sample size180
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Bimodality therapy group: two courses of systemic chemotherapy followed by surgeryTrimodality therapy group: two courses of systemic chemotherapy with concurrent thoracic radiotherapy followed by surgeryChemotherapy regimen consists of carboplatin and docetaxel on day 1. Two courses of chemotherapy with 3 weeks interval is plannedPatients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy. Radiotherapy begins on day 1, concurrently with chemotherapy.(The total dose of radiation is 40 Gy, 2 Gy/fraction/day)

Outcome(s)

Primary OutcomeFive-year survival
Secondary Outcometoxicity of a preoperative treatment and a response rate, resection rate, complete resection rate, unresectable rate, downstaging rate, postoperative mortality and morbidity, hospital mortality, disease-free survival rate, median survival time, pattern of recurrence (first site of relapse)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria1) Pathological diagnosis of non-small cell lung cancer is necessary. Ipsilateral pathologically-proved mediastinal lymph node with shortest diameter of larger than 1 cm is required.2) Pretreatment lesions are respectable without extranodal invasion. 3) No prior treatment for lung cancer4) Measurable disease5) Age 20 to 70 years6) Performance status (ECOG criteria) 0-17) Adequate organ functions WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul, T.Bil less than 1.5mg/dl, serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 40mg/dl, PaO2 more than 70torr, Forced expiratory volume in 1 secnd more than 1.5L 8) No prior chemotherapy or radiotherapy for the treatment of other malignancies is essential.9) Written informed consent to participate in the trial is necessary
Exclude criteria1)Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of completely resected early gastric cancer,uterine cervical cancer, completely resected skin malignancies (except malignant melanoma)are acceptable. 2)Uncontrollable angina or myocardial infarction within the past 3 months. Severe heart disease, arrhythmia requiring treatment. 3)Uncontrollable hypertension and Diabetes Mellitus. 4)Patients with severe COPD (FEV1.0percent less than 65)or pulmonary fibrosis recognized with computed tomography scanning. 5)Weight loss more than 10 percent within the past 6 months 6)Women during pregnancy or lactating. 7)ther unsuitable patient judged by a physician.

Related Information

Contact

public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Nobuyuki Katakami
Address 4-6, Minatojima Nakamachi Chuo-ku,Kobe 650-0046, Japan Japan
Telephone 078-302-4321
E-mail
Affiliation Kobe City General Hospital Division of pulmonary medicine