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

NCT ID: NCT02189967

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional fractionation

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

Group Type ACTIVE_COMPARATOR

conventional fractionation

Intervention Type RADIATION

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.

accelerated fraction

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

Group Type ACTIVE_COMPARATOR

accelerated fraction

Intervention Type RADIATION

In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

Interventions

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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.

Intervention Type 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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Consortium for Translational Cancer Research

OTHER

Sponsor Role collaborator

National Center for Radiation Research in Oncology Dresden/Heidelberg

OTHER

Sponsor Role collaborator

Radiation Oncology Working Group of the German Cancer Society

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rebecca Bütof

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Bütof, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology

Locations

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Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology

Dresden, , Germany

Site Status

Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology

Freiburg im Breisgau, , Germany

Site Status

Praxis für Strahlentherapie Hamburg-Harburg

Hamburg, , Germany

Site Status

Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology

Homburg, , Germany

Site Status

Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology

München, , Germany

Site Status

Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology

München, , Germany

Site Status

Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine

Stuttgart, , Germany

Site Status

Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology

Tübingen, , Germany

Site Status

SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University

Olsztyn, , Poland

Site Status

Countries

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Germany Poland

References

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Butof R, Koi L, Lock S, Appold S, Drewes S, Koschel D, Kotzerke J, Nestle U, Adebahr S, Zips D, Heinzelmann F, Hehr T, Bucher D, Heide J, Belka C, Manapov F, Wasilewska-Tesluk E, Fleckenstein J, Krause M, Troost EGC, Baumann M. Accelerated vs. conventionally fractionated postoperative radiotherapy of non-small cell lung cancer-final results of the prematurely terminated PORTAF trial. Strahlenther Onkol. 2025 Jul 15. doi: 10.1007/s00066-025-02422-y. Online ahead of print.

Reference Type DERIVED
PMID: 40663146 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29262836 (View on PubMed)

Other Identifiers

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STR-PORTAF-2014

Identifier Type: -

Identifier Source: org_study_id

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