Clinical trial NCT02189967: Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Official title: Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: non-small cell lung cancer
radiotherapy
accelerated fractionation
conventional fractionation
postoperative
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Consortium for Translational Cancer Research
name: National Center for Radiation Research in Oncology Dresden/Heidelberg
name: Radiation Oncology Working Group of the German Cancer Society
First posted: 2014-07-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: assessment of local tumor control
timeFrame: 36 months after therapy
Secondary outcomes:
measure: overall survival
timeFrame: 36 months after therapy
measure: local recurrence-free survival
timeFrame: 36 months after therapy
measure: acute toxicity
timeFrame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.
measure: quality of life
timeFrame: 36 months after therapy
measure: distant metastases-free survival
timeFrame: 36 months after therapy
measure: late toxicity
timeFrame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
city: Hamburg
country: Germany
facility: Praxis für Strahlentherapie Hamburg-Harburg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology
city: München
country: Germany
facility: Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology
city: München
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
city: Olsztyn
country: Poland
facility: SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University
Study officials:
affiliation: Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
name: Rebecca Bütof, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butof R, Simon M, Lock S, Troost EGC, Appold S, Krause M, Baumann M. PORTAF - postoperative radiotherapy of non-small cell lung cancer: accelerated versus conventional fractionation - study protocol for a randomized controlled trial. Trials. 2017 Dec 20;18(1):608. doi: 10.1186/s13063-017-2346-0.