Short summary

This randomized phase III study 2-arm investigates the effect of increasing the radiation dose by definitive chemo-radiotherapy of patients with inoperable loco-regional advanced Non-Small Cell Lung Cancer (NSCLC). The radiation dose is increased to tumor and lymph nodes based on inhomogeneous dose distribution determined by the most active (FDG-PET criteria) area of the node in the experimental arm. Patients in the control arm will receive standard uniform dose distribution. In both, the treatment arms are over 33 fractions. In the experimental arm the dose is kept as high as possible, taking into consideration normal tissue tolerance. In the control arm 66 Gy.

Rationale

NSCLC has very often spread to the lymph nodes between the lungs or grown into the surroundings at the time of diagnosis. Then concurrent chemo-radiation is the treatment of choice. However, survival is poor with a median survival of 20 months and a 5 year survival of 15-20% in clinical trials. Lack of loco-regional control is one of the reasons for the poor survival and improvement in the loco-regional control by increasing the radiation dose will probably lead to an improved survival. Complications in the normal tissue, especially the lungs, may be fatal and are the limiting factors. The risk of side effects is dependent on the dose to normal tissue, and the volume of normal tissue being irradiated. In this study, we try to increase the dose to the portion of the tumor most resistant to radiotherapy without increasing the volume of and dose to irradiated crucial normal tissue.

Description of the cohort

Patients with newly diagnosed locally advanced NSCLC suitable for radical chemo-radiation to a dose of 66 Gy. The patients have to be performance status 0-1, have no other active cancer, and be in general stable medical condition.

Data and biological material

Data on patients' demographics, stage, histology, radiotherapy, volume and dose. Outcome date such as survival, local-control, toxicity.

Collaborating researchers and departments

Department of Oncology, Odense University Hospital

• Consultant Olfred Hansen, MD, PhD, MPO
• Consultant Tine Schytte, MD, PhD

Laboratory of Radiation Physics, Odense University Hospital

• Medical Physicist Tine Bjørn Nielsen, Cand. Scient., PhD
• Professor Carsten Brink, Cand. Scient, PhD
• Medical Physicist Morten Nielsen, Cand. Scient, PhD

Department of Nuclear Medicine, Odense University Hospital

• Consultant Henrik Petersen, MD

Department of Oncology, Aarhus University Hospital

• Consultant Marianne Marquard Knap, MD, PhD
• Staff Specialist Azza Ahmed Khalil, MD, PhD

Department of Medial Physics, Aarhus University Hospital

• Medical Physicist Ditte Sloth Møller, Cand. Scient., PhD
• Medical Physicist Lone Hoffmann, Cand. Scient., PhD
• Medical Physicist Christina Maria Lutz, Cand. Scient.

Department of Nuclear Medicine, Aarhus University Hospital

• Staff Specialist Ate Haraldsen, MD

Department of Oncology, Vejle Hospital

• Consultant Christa Haugaard Nyhus, MD

Laboratory of Radiation Physics, Vejle Hospital

• Medical Physicist Ane Lindegaard Appelt, Cand. Scient., PhD
• Medical Physicist Mikkel Drøgemüller Lund, Cand Scient. PhD

Department of Nuclear Medicine, Vejle Hospital

• Consultant Paw Holdgaard, MD