Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

radiotherapy with conventional fractionation (5 x 2Gy per week)

radiotherapy with accelerated fraction (7 x 2 Gy per week)

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.

conventional fractionation

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

accelerated fraction

Rebecca Bütof, Dr.

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.

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

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

Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.

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

The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.

The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.

Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.

The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden

Spots Global Cancer Trial Database for accelerated fraction