Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non-small cell lung cancer, radiotherapy, accelerated fractionation, conventional fractionation, postoperative
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: conventional fractionation Type: Radiation
Name: accelerated fraction Type: Radiation
Overall Status
Recruiting
Summary
In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy (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).
Detailed Description
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- histologically confirmed non-small cell lung cancer

- previous tumor resection with curative intention

- postoperative indication for irradiation (> pN1 and/ or R1)

- 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)

- 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
Charité - Universitätsmedizin Berlin, Department of Radiation Oncology and Radiotherapy
Berlin, Germany
Status: Not yet recruiting
Contact: Volker Budach, Prof. - +49 30 450 527 152
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, Germany
Status: Recruiting
Contact: Michael Baumann, Prof. - +49 351 458 2238 - str.studien@uniklinikum-dresden.de
Universitätsklinikum Erlangen, Department of Radiation Therapy and Radiation Oncology
Erlangen, Germany
Status: Not yet recruiting
Contact: Rainer Fietkau, Prof. - +49 9131 85 33405
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
Freiburg, Germany
Status: Not yet recruiting
Contact: Anca Grosu, Prof. - +49 761 270 94610
Universitätsklinikum Halle (Saale), Department of Radiation Therapy and Radiation Oncology
Halle, Germany
Status: Not yet recruiting
Contact: Dirk Vordermark, Prof. - +49 345 557 4310
Universitätsklinikum Heidelberg, Department of Radiation Therapy and Radiation Oncology
Heidelberg, Germany
Status: Not yet recruiting
Contact: Jürgen Debus, Prof. - +49 6221 / 56 82 01
Universitätsmedizin Mainz, Department of Radiation Therapy and Radiation Oncology
Mainz, Germany
Status: Not yet recruiting
Contact: Heinz Schmidberger, Prof. - +49 6131 17-3851
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology
München, Germany
Status: Not yet recruiting
Contact: Claus Belka, Prof. - +49 89 7095 4520
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology
München, Germany
Status: Not yet recruiting
Contact: Stephanie Combs, Prof. - + 49 89 4140-4501
Universitätsmedizin Rostock, Department of Radiation Therapy and Radiation Oncology
Rostock, Germany
Status: Not yet recruiting
Contact: Guido Hildebrandt, Prof. - +49 0381 - 494 9000
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
Tübingen, Germany
Status: Not yet recruiting
Contact: Daniel Zips, Prof. - +49 7071/29-8 21 65
Uniwersyteckie Centrum Kliniczne, Department of Radiation Therapy and Radiation Oncology
Gdańsk, Poland
Status: Not yet recruiting
Contact: Rafał Dziadziuszko, Prof. - +48 58 349 2271
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University
Olsztyn, Poland
Status: Not yet recruiting
Contact: Lucyna Kępka, Dr. - lucynak@coi.waw.pl
Great Poland Cancer Center, Department of Radiotherapy
Poznań, Poland
Status: Not yet recruiting
Contact: Piotr Milecki, Prof. - piotr.milecki@wco.pl
Start Date
August 2014
Completion Date
August 2023
Sponsors
Technische Universität Dresden
Source
Technische Universität Dresden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page