drugset / Trial / NCT00132665
Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
Phase 3
Completed
200 enrolled
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-07
- Primary completion
- 2011-11
- Completion
- 2012-02
Outcome
Met primary endpoint
paper the difference in overall survival favoured the chemoradiotherapy group. PMID 22622008 ↗
paper hazard ratio 0·68, 95·4% CI 0·47-0·98, stratified log-rank test one-sided p value=0·0179 PMID 22622008 ↗
Publications
- Atagi 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.
- Atagi 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 30 mg/m2 | — |