NCT02189967

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

4.8 years

First QC Date

May 22, 2014

Last Update Submit

July 21, 2020

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancerradiotherapyaccelerated fractionationconventional fractionationpostoperative

Outcome Measures

Primary Outcomes (1)

  • 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).

    36 months after therapy

Secondary Outcomes (6)

  • overall survival

    36 months after therapy

  • local recurrence-free survival

    36 months after therapy

  • acute toxicity

    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.

  • quality of life

    36 months after therapy

  • distant metastases-free survival

    36 months after therapy

  • +1 more secondary outcomes

Study Arms (2)

conventional fractionation

ACTIVE COMPARATOR

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

Radiation: conventional fractionation

accelerated fraction

ACTIVE COMPARATOR

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

Radiation: accelerated fraction

Interventions

conventional fractionationRADIATION

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.

conventional fractionation
accelerated fractionRADIATION

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

accelerated fraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology

Dresden, 01307, Germany

Location

Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology

Freiburg im Breisgau, 79106, Germany

Location

Praxis für Strahlentherapie Hamburg-Harburg

Hamburg, 21075, Germany

Location

Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology

Homburg, Germany

Location

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

München, 81377, Germany

Location

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

München, 81675, Germany

Location

Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine

Stuttgart, Germany

Location

Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology

Tübingen, 72016, Germany

Location

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

Olsztyn, 10-228, Poland

Location

Related Publications (2)

  • 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.

    PMID: 40663146DERIVED

  • 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.

    PMID: 29262836DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rebecca Bütof, Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2014

First Posted

July 15, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2019

Study Completion

July 1, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(8)PL(1)