Clinical trial · Interventional
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)
NCT00132665CI-TRIAL-00008624completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A: Radiotherapy alone | Procedure | — | UNRESOLVED |
| B: CBDCA and Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Procedure/Surgery: A: Radiotherapy alone
- interventionNames
- Procedure: A: Radiotherapy alone
- type
- EXPERIMENTAL
- label
- 2
- description
- Drug: B: CBDCA and Radiotherapy
- interventionNames
- Drug: B: CBDCA and Radiotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- During the study conduct
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 71 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAtagi S, Mizusawa J, Ishikura S, Takahashi T, Okamoto H, Tanaka H, Goto K, Nakagawa K, Harada M, Takeda Y, Nogami N, Fujita Y, Kasai T, Kishi K, Sawa T, Takeda K, Tomii K, Satouchi M, Seto T, Ohe Y. Chemoradiotherapy in Elderly Patients With Non-Small-Cell Lung Cancer: Long-Term Follow-Up of a Randomized Trial (JCOG0301). Clin Lung Cancer. 2018 Sep;19(5):e619-e627. doi: 10.1016/j.cllc.2018.04.018. Epub 2018 May 5. PMID 29887243
- DERIVEDAtagi S, Kawahara M, Yokoyama A, Okamoto H, Yamamoto N, Ohe Y, Sawa T, Ishikura S, Shibata T, Fukuda H, Saijo N, Tamura T; Japan Clinical Oncology Group Lung Cancer Study Group. Thoracic radiotherapy with or without daily low-dose carboplatin in elderly patients with non-small-cell lung cancer: a randomised, controlled, phase 3 trial by the Japan Clinical Oncology Group (JCOG0301). Lancet Oncol. 2012 Jul;13(7):671-8. doi: 10.1016/S1470-2045(12)70139-0. Epub 2012 May 22. PMID 22622008