Status:
COMPLETED
Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
71+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00132665
Start Date
July 1 2003
End Date
February 1 2012
Last Update
December 7 2012
Active Locations (37)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
Aichi Cancer Center,Aichi Hospital
Okazaki, Aichi-ken, Japan, 444-0011
3
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Natsuyama, Ehime, Japan, 790-0007