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

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ClinicalTrials.gov Identifier: NCT02189967

Recruitment Status : Completed

First Posted : July 15, 2014

Last Update Posted : July 22, 2020

Sponsor:

Collaborators:

German Consortium for Translational Cancer Research

National Center for Radiation Research in Oncology Dresden/Heidelberg

Radiation Oncology Working Group of the German Cancer Society

Information provided by (Responsible Party):

Dr. Rebecca Bütof, Technische Universität Dresden

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Radiation: conventional fractionation Radiation: accelerated fraction	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	38 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
Actual Study Start Date :	November 2014
Actual Primary Completion Date :	August 2019
Actual Study Completion Date :	July 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: conventional fractionation radiotherapy with conventional fractionation (5 x 2Gy per week)	Radiation: conventional fractionation 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.
Active Comparator: accelerated fraction radiotherapy with accelerated fraction (7 x 2 Gy per week)	Radiation: accelerated fraction In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

Outcome Measures

Primary Outcome Measures :

assessment of local tumor control [ Time Frame: 36 months after therapy ]
Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).

Secondary Outcome Measures :

overall survival [ Time Frame: 36 months after therapy ]
Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.
local recurrence-free survival [ Time Frame: 36 months after therapy ]
Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
acute toxicity [ Time Frame: 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. ]
The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.
quality of life [ Time Frame: 36 months after therapy ]
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-free survival [ Time Frame: 36 months after therapy ]
Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.
late toxicity [ Time Frame: 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. ]
The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189967

Locations

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Germany
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, Germany, 01307
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
Freiburg, Germany, 79106
Praxis für Strahlentherapie Hamburg-Harburg
Hamburg, Germany, 21075
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology
Homburg, Germany
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology
München, Germany, 81377
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology
München, Germany, 81675
Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine
Stuttgart, Germany
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
Tübingen, Germany, 72016
Poland
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University
Olsztyn, Poland, 10-228

Sponsors and Collaborators

Technische Universität Dresden

German Consortium for Translational Cancer Research

National Center for Radiation Research in Oncology Dresden/Heidelberg

Radiation Oncology Working Group of the German Cancer Society

Investigators

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Principal Investigator:	Rebecca Bütof, Dr.	Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bütof R, Simon M, Löck 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.

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Responsible Party:	Dr. Rebecca Bütof, Principal Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier:	NCT02189967
Other Study ID Numbers:	STR-PORTAF-2014
First Posted:	July 15, 2014 Key Record Dates
Last Update Posted:	July 22, 2020
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Dr. Rebecca Bütof, Technische Universität Dresden:


non-small cell lung cancer radiotherapy accelerated fractionation conventional fractionation postoperative

Additional relevant MeSH terms:

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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms

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