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

Technische Universität Dresden38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

conventional fractionationRADIATION

In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.

accelerated fractionRADIATION

In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology

Dresden, Germany

Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology

Freiburg im Breisgau, Germany

Praxis für Strahlentherapie Hamburg-Harburg

Hamburg, Germany

Outcomes

Primary Outcomes

assessment of local tumor control

Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).