Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
71 Years
N/A
Both
Non-Small-Cell Lung Carcinoma
Trial Information
Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
During the study conduct
Safety Issue:
No
Principal Investigator
Masaaki Kawahawa, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kinki-Chuo Chest Medical Center
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG0301
NCT ID:
NCT00132665
Start Date:
July 2003
Completion Date:
February 2012
Related Keywords:
- Non-Small-Cell Lung Carcinoma
- non-small cell lung cancer
- elderly patients
- carboplatin
- chemoradiotherapy
- Non-small cell Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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