Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Procedure: A: Radiotherapy alone
* Drug: B: CBDCA and Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: A: Radiotherapy alone | Procedure: A: Radiotherapy alone<br>* Procedure/Surgery: A: Radiotherapy alone<br>|
| Experimental: 2<br>Drug: B: CBDCA and Radiotherapy | Drug: B: CBDCA and Radiotherapy<br>* Drug: B: CBDCA and Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy