High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Timeline
- Start
- 2007-11
- Primary completion
- 2013-06
- Completion
- 2022-05-20
Outcome
Missed primary endpoint
paper 74 Gy radiation given in 2 Gy fractions with concurrent chemotherapy was not better than 60 Gy plus concurrent chemotherapy for patients with stage III non-small-cell lung cancer PMID 25601342 ↗
paper Addition of cetuximab to concurrent chemoradiation and consolidation treatment provided no benefit in overall survival for these patients. PMID 25601342 ↗
Publications
- Results Bradley JD, Hu C, Komaki RR, Masters GA, Blumenschein GR, Schild SE, Bogart JA, Forster KM, Magliocco AM, Kavadi VS, Narayan S, Iyengar P, Robinson CG, Wynn RB, Koprowski CD, Olson MR, Meng J, Paulus R, Curran WJ Jr, Choy H. Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Mar 1;38(7):706-714. doi: 10.1200/JCO.19.01162. Epub 2019 Dec 16.
- Chun SG, Hu C, Komaki RU, Timmerman RD, Schild SE, Bogart JA, Dobelbower MC, Bosch W, Kavadi VS, Narayan S, Iyengar P, Robinson C, Rothman J, Raben A, Augspurger ME, MacRae RM, Paulus R, Bradley JD. Long-Term Prospective Outcomes of Intensity Modulated Radiotherapy for Locally Advanced Lung Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1111-1115. doi: 10.1001/jamaoncol.2024.1841.
- Zhang Z, Wang Z, Luo T, Yan M, Dekker A, De Ruysscher D, Traverso A, Wee L, Zhao L. Computed tomography and radiation dose images-based deep-learning model for predicting radiation pneumonitis in lung cancer patients after radiation therapy. Radiother Oncol. 2023 May;182:109581. doi: 10.1016/j.radonc.2023.109581. Epub 2023 Feb 25.
- McWilliam A, Abravan A, Banfill K, Faivre-Finn C, van Herk M. Demystifying the Results of RTOG 0617: Identification of Dose Sensitive Cardiac Subregions Associated With Overall Survival. J Thorac Oncol. 2023 May;18(5):599-607. doi: 10.1016/j.jtho.2023.01.085. Epub 2023 Feb 3.
- McKenzie E, Zhang S, Zakariaee R, Guthier CV, Hakimian B, Mirhadi A, Kamrava M, Padda SK, Lewis JH, Nikolova A, Mak RH, Atkins KM. Left Anterior Descending Coronary Artery Radiation Dose Association With All-Cause Mortality in NRG Oncology Trial RTOG 0617. Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1138-1143. doi: 10.1016/j.ijrobp.2022.11.033. Epub 2022 Nov 24.
- Movsas B, Hu C, Sloan J, Bradley J, Komaki R, Masters G, Kavadi V, Narayan S, Michalski J, Johnson DW, Koprowski C, Curran WJ Jr, Garces YI, Gaur R, Wynn RB, Schallenkamp J, Gelblum DY, MacRae RM, Paulus R, Choy H. Quality of Life Analysis of a Radiation Dose-Escalation Study of Patients With Non-Small-Cell Lung Cancer: A Secondary Analysis of the Radiation Therapy Oncology Group 0617 Randomized Clinical Trial. JAMA Oncol. 2016 Mar;2(3):359-67. doi: 10.1001/jamaoncol.2015.3969.
- Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 2 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 45 mg/m2 | Intravenous |