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

• ClinicalTrials.gov Identifier: NCT02189967
• Recruitment Status: Completed
• First Posted: July 15, 2014
• Last Update Posted: July 22, 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
• 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

• 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

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 :

1. 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 :

1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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

• 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

Locations

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

• 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.

• 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
• 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:

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