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

Japan Clinical Oncology Group

Status and phase

Completed

Phase 3

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Procedure: A: Radiotherapy alone

Drug: B: CBDCA and Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00132665

JCOG0301

C000000059 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

71+ years old

Volunteers

No Healthy Volunteers

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