NCT03055715

Brief Summary

The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before initiation of radiotherapy and its changes during radiotherapy and to correlate them with retrospectively recorded patient data, as well as with prognostic and therapeutic outcome after definite radiotherapy of locally advanced NSCLC in stage UICC III.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
5 countries

22 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

February 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

February 14, 2017

Last Update Submit

May 1, 2018

Conditions

Non Small Cell Lung Cancer Stage III

Keywords

NSCLCRadiotherapyyoung DEGROtumor volumelung cancerradiochemotherapyprognostic factors

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (months)

    from the start of Radiotherapy until death / last seen during follow up

    5 months

Secondary Outcomes (3)

  • Absolute Basal Gross Tumor Volume (ml) before Radiotherapy (GTV1)

    5 months

  • Absolute Gross Tumor Volume before Radiation Boost (GTV2)

    5 months

  • Relative Gross Tumor Volume Changes (delta GTV related to basal GTV)

    5 months

Study Arms (1)

Locally advanced NSCLC-patients

Inoperable stage III (A and B) non-small-cell lung cancer (NSCLC) with indication for radical radiotherapy.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Locally advanced, inoperable stage III (A and B) non-small-cell lung cancer without prior surgery

You may qualify if:

  • Histologically confirmed NSCLC (Adeno / SCC) Stage UICC III A or B
  • CT based radiation treatment planning (PET- or PET-CT-based if available)
  • completed curative-intended radiotherapy ± chemotherapy (achieved total dose ≥ 60 Gy normofractionated or ≥ 50 Gy hypofractionated)

You may not qualify if:

  • Stereotactic radiotherapy
  • Second malignancy \<5 years before diagnosis of NSCLC
  • Pleural effusion ipsilateral, extensive atelectasis ipsilateral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Univ.-Klinik für Strahlentherapie-Radioonkologie

Innsbruck, 6020, Austria

Location

Iridium Cancer Network

Antwerp, Belgium

Location

Department of Radiooncology, Charité Campus Mitte und Campus Virchow Berlin

Berlin, 10117, Germany

Location

Department of Radiooncology Cologne

Cologne, 50937, Germany

Location

Department of Radiooncology Dresden

Dresden, 01307, Germany

Location

Department of Radiooncology, Duesseldorf

Düsseldorf, 40210, Germany

Location

Department of Radiooncology, Düsseldorf

Düsseldorf, 40225, Germany

Location

Department of Radiooncology, Erlangen

Erlangen, Germany

Location

Department of Radiooncology, Halle

Halle, 06120, Germany

Location

Department of Radiooncology, Hamburg

Hamburg, 20246, Germany

Location

Department of Radiooncology, Hannover

Hanover, 30625, Germany

Location

Department of Radiooncology, Heidelberg

Heidelberg, 69120, Germany

Location

Department of Radiooncology, Jena

Jena, 07743, Germany

Location

Department of Radiooncology, Kiel

Kiel, 24105, Germany

Location

Department of Radiooncology Lübeck

Lübeck, 23562, Germany

Location

Department of Radiooncology, Mannheim

Mannheim, 68167, Germany

Location

Department of Radiooncology, Munich (LMU, Campus Großhadern)

Munich, 81377, Germany

Location

Department of Radiooncology, Munich (TUM)

Munich, Germany

Location

Department of Radiooncology, Muenster

Münster, 48143, Germany

Location

Department of Radiooncology, Regensburg

Regensburg, 93047, Germany

Location

Department of Radiooncology, Sevilla

Seville, Spain

Location

Klinik für Strahlentherapie, St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian Ostheimer, MD

    Klinik fuer Strahlentherapie, Martin-Luther-Universitaet Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 16, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

DE(18)AU(1)ES(1)BE(1)CH(1)