Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).

This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.

Inclusion Criteria:

• histologically confirmed non-small cell lung cancer
• previous tumor resection with curative intention
• postoperative indication for irradiation (> pN1 and/ or R1)
• R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging
• exclusion of distant metastases (M0)
• age > 18 years
• good general condition (ECOG performance status 0 or 1)
• written informed consent
• appropriate compliance to ensure close follow-up
• women of childbearing age: adequate contraception

Exclusion Criteria:

• histologically confirmed small cell lung cancer
• distant metastases
• no written informed consent or lack of cooperation relating to therapy or follow-up
• previous (< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers)
• for proton therapy: heart pacemaker
• previous radiotherapy of the thorax or lower neck region
• pregnancy or lactation
• participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study