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)

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) - 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000060

Enrollment

200

Registered

2005-08-15

Start date

2003-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Non-small cell Lung Cancer

Interventions

Radiotherapy alone CBDCA and Radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically and/or cytologically proven NSCLC, (2) Unresectable disease, (3) 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, (4) a required radiation field of less than one half of one lung, (5) measurable disease, (6) no previous chemotherapy or radiotherapy, (7) age>=71, (8) inappropriate to recieve cisplatin-based combination chemotherapy, (9) ECOG PS of 0-2, (10) adequate bone marrow, lung, hepatic, renal function, (11) written informed consent.

Exclusion criteria

Exclusion criteria: (1) active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, severe other comorbity, (2) synchronous cancer or metachronous (within 5 years) malignancy, (3) interstitial pneumonia or active lung fibrosis on chest X-ray, (4) severe chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma, (5) pleural or pericardial effusion, (6) a history of severe hypersensitivity, (7) mental disorder, (8) judging of inappropriate condition for this study by physician.

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
Response rate, Adverse events, Progression-free survival, Pattern of progression/relapse	—

Countries

Japan

Contacts

Public ContactShinji Atagi, MD

JCOG0301 Coordinating Office Department of Internal Medicine, Kinki-Chuo Chest Medical Center

JCOG_sir@ml.jcog.jp072-252-3021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026