Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
- Conditions
- Non-Small-Cell Lung Carcinoma
- Registration Number
- NCT00132665
- Lead Sponsor
- Japan Clinical Oncology Group
- Brief Summary
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.
- Detailed Description
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Histologically and/or cytologically proven NSCLC
- Unresectable disease
- Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
- A required radiation field of less than one half of one lung
- Measurable disease
- No previous chemotherapy or radiotherapy
- Age >= 71
- Unable to receive cisplatin-based combination chemotherapy
- ECOG performance status (PS) of 0-2
- Adequate bone marrow, lung, hepatic, and renal function
- Written informed consent
- Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
- Synchronous cancer or metachronous (within 5 years) malignancy
- Interstitial pneumonia or active lung fibrosis on chest X-ray
- Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
- Pleural or pericardial effusion
- A history of severe hypersensitivity
- Mental disorder
- Judging of inappropriate condition for this study by physician
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival During the study conduct
- Secondary Outcome Measures
Name Time Method Response rate During the study conduct Adverse events During the study conduct Progression-free survival During the study conduct Pattern of progression/relapse During the study conduct
Trial Locations
- Locations (37)
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Aichi Cancer Center,Aichi Hospital
🇯🇵Okazaki, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Natsuyama, Ehime, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota, Gunma, Japan
National Nishigunma Hospital
🇯🇵Shibukawa, Gunma, Japan
National Hospital Organization, Dohoku National Hospital
🇯🇵Asahikawa, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Medical Center for Adults
🇯🇵Akashi, Hyogo, Japan
Kobe City General Hospital
🇯🇵Kobe, Hyogo, Japan
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