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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
conventional fractionation
accelerated fraction
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring non-small cell lung cancer, radiotherapy, accelerated fractionation, conventional fractionation, postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
  • Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
  • Praxis für Strahlentherapie Hamburg-Harburg
  • Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology
  • Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology
  • Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology
  • Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine
  • Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
  • SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

conventional fractionation

accelerated fraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

overall survival
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
Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
acute toxicity
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
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
Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.
late toxicity
The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

Full Information

First Posted
May 22, 2014
Last Updated
July 21, 2020
Sponsor
Technische Universität Dresden
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
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1. Study Identification

Unique Protocol Identification Number
NCT02189967
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
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

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
non-small cell lung cancer, radiotherapy, accelerated fractionation, conventional fractionation, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional fractionation
Arm Type
Active Comparator
Arm Description
radiotherapy with conventional fractionation (5 x 2Gy per week)
Arm Title
accelerated fraction
Arm Type
Active Comparator
Arm Description
radiotherapy with accelerated fraction (7 x 2 Gy per week)
Intervention Type
Radiation
Intervention Name(s)
conventional fractionation
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
accelerated fraction
Intervention Description
In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
Primary Outcome Measure Information:
Title
assessment of local tumor control
Description
Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
Time Frame
36 months after therapy
Secondary Outcome Measure Information:
Title
overall survival
Description
Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.
Time Frame
36 months after therapy
Title
local recurrence-free survival
Description
Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
Time Frame
36 months after therapy
Title
acute toxicity
Description
The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.
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.
Title
quality of life
Description
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.
Time Frame
36 months after therapy
Title
distant metastases-free survival
Description
Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.
Time Frame
36 months after therapy
Title
late toxicity
Description
The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Bütof, Dr.
Organizational Affiliation
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Praxis für Strahlentherapie Hamburg-Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology
City
Homburg
Country
Germany
Facility Name
Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine
City
Stuttgart
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology
City
Tübingen
ZIP/Postal Code
72016
Country
Germany
Facility Name
SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29262836
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.
Results Reference
derived

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

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