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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132665

Enrollment

200

Registered

2005-08-22

Start date

2003-07-31

Completion date

2012-02-29

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy

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.

Interventions

PROCEDUREA: Radiotherapy alone

Procedure/Surgery: A: Radiotherapy alone

DRUGB: CBDCA and Radiotherapy

Drug: B: CBDCA and Radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

71 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall survival	During the study conduct

Secondary

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026