Lung-ART opens within EORTC for patients with completely resected NSCLC and mediastinal N2 involvement

Non-small cell lung cancers (NSCLCs) are not only a fairly frequent form of cancer, but they also have a poor prognosis. Worldwide, there are over one million new cases of lung cancer diagnosed each year. Roughly 80% of these are NSCLCs, and the five year survival rate for these patients is not more than 14%. Furthermore, disease-free survival for patients with surgically removed NSCLC which has spread to mediastinal lymph nodes on the same side of the tumor is about 30% at three years, and the risk of local recurrence for these patients at three years is approximately 30%. However, it is thought that these outcomes could be improved by adding conformal post-operative radiotherapy to the standard treatment.

The phase III EORTC 22055 – 08053 Lung Adjuvant Radiotherapy Trial (LungART) investigates whether conformal post-operative radiotherapy improves disease-free survival in NSCLC patients with a completely resected tumor which has spread to mediastinal nodes on the same side of the tumor. For these patients, adjuvant chemotherapy is often used as part of standard treatment, so in this study patients may receive chemotherapy either before or after surgery, but cannot receive chemotherapy during the conformal radiotherapy.

Dr. Cecile Le Pechoux of the Institut Gustave Roussy, Villejuif, and Coordinator of this study says “Lung ART is a multidisciplinary trial that addresses a highly relevant question of therapeutic strategy in a frequent cancer with a poor prognosis. Other than a new trial in China, Lung ART is the only ongoing phase III trial in patients with histologically/cytologically proven N2 disease comparing post-operative radiotherapy to no post-operative radiotherapy and utilizing all major progress achieved in NSCLC. It associates conformal radiotherapy quality control and translational research. Already, 196 patients have been included in France (IFCT-0503) and the United Kingdom (UK 11/NW/0075). I am happy to welcome EORTC investigators. Together, we will provide an answer about the benefit of postoperative radiotherapy after several decades of hesitations and controversies.”

Lung ART plans to accrue 700 patients and will eventually be conducted in 100 sites in six countries: France, United Kingdom, Belgium, Poland, Germany and Switzerland. This Intergroup trial is led by the Institut de Cancérologie Gustave Roussy in collaboration with the EORTC Lung Cancer and Radiation Oncology Groups, Intergroupe Francophone de Cancérologie Thoracique, and Manchester Academic Health Science Centre – Clinical Trials Unit. The database will be stored at the Institut de Cancérologie Gustave Roussy.

EORTC trial 22055 – 08053 is an academic study supported by grants from the EORTC Lung Cancer Group, the EORTC Radiation Oncology Group, the EORTC Academic Fund, and the French National Cancer Institute, PHRC (Programme Hospitalier de Recherche Clinique en Cancérologie) without support from the pharmaceutical industry. There is a clear need to fund trials such as Lung ART, because these trials are essential for improving patient outcomes and are not conducted for commercial gain.

For more information concerning EORTC trial 22055 – 08053 please contact: www.eortc.org/contact

John Bean, PhD
EORTC, Medical Science Writer