Image guided stereotactic body radiation therapy for patients with inoperable centrally located early stage non-small-cell lung cancer
Lung cancer is a widespread disease with an estimated 409,900 new cases and 353,500 deaths in Europe in 2012. Non-small-cell lung cancer (NSCLC) accounts for approximately eight out of every ten lung cancer cases, and just 16% of the patients with this disease are still alive five years after being diagnosed. This poor survival is largely attributed to these patients being diagnosed at an advanced stage. Three fourths of patients diagnosed at an earlier stage are still alive after five years.
The current standard of care for medically fit patients with limited NSCLC tumors is surgical resection which offers the potential of local control of tumors in up to 96% of the patients at early stage small volume disease. However, roughly one fourth of patients with NSCLC are medically inoperable because of coexisting morbidities or poor general condition, mostly a consequence of a long smoking history or heart disease. For these patients, traditionally performed conventional fractionated radiotherapy has been the standard of care. Such treatment was superior to best supportive care, but still associated with poor survival rates of just 30% after five years.
Dr. Ursula Nestle of Universitaetsklinikum Freiburg, Germany, and coordinator for this study says, “Stereotactic body radiation therapy, SBRT, is more effective than traditionally performed conventional radiotherapy in peripherally located lung tumors, because it delivers a higher biologically effective dose. If we combine this high-precision dose delivery with modern imaging techniques, we can reduce the target volume size and thereby decrease exposure of healthy tissue to high doses as well as the risk of subsequent toxicity. The effectiveness of SBRT for centrally located tumors has been reported in mainly retrospective single center studies, but efficacy and safety must still be evaluated in a prospective multicenter setting. LungTech will also give us the opportunity to evaluate the role of FDG-PET/CT (fluorodeoxyglucose positron emission tomography computed tomography) to monitor tumor progression and toxicity of SBRT.”
The phase II EORTC 22113 – 08113 LungTech trial will assess the effectiveness and the safety of this treatment in patients with medically inoperable, early stage, centrally located, NSCLC and in those unwilling to undergo surgical treatment in preparation for a randomized phase III trial. In a limited number of recruiting centers offering 4D FDG-PET/CT, some optional translational sub-projects are planned to be performed to compare nodal staging but also target volume contouring with 4D versus 3D FDG-PET/CT. Another translational sub-project aims to externally validate the local progression criteria proposed by Huang et al.
EORTC trial 22113 – 08113 is coordinated by the EORTC Radiation Oncology Group in collaboration with the EORTC Lung Cancer Group and will enroll 150 patients at 23 sites located in seven countries: Belgium, France, Germany, Poland, Switzerland, The Netherlands, and The United Kingdom. This trial is supported by the Deutsche Krebshilfe, Clinical Trials Awards and Advisory Committee, the EORTC Academic fund, and the EORTC Radiation Oncology and Lung Cancer Groups.
John Bean, PhD
EORTC, Medical Science Writer