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Prognostic Evaluation of Tumor Volume and Its Changes in Radical Radiotherapy of Advanced NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055715
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Radiation Oncology Working Group of the German Cancer Society
Information provided by (Responsible Party):
Christian Ostheimer, MD, Martin-Luther-Universität Halle-Wittenberg

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.

Condition or disease
Non Small Cell Lung Cancer Stage III

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Study Type : Observational
Actual Enrollment : 346 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Retrospective Prognostic Evaluation of Tumor Volume and Their Change in the Curative-intended, Radical Radiotherapy of Locally Advanced NSCLC
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Locally advanced NSCLC-patients
Inoperable stage III (A and B) non-small-cell lung cancer (NSCLC) with indication for radical radiotherapy.



Primary Outcome Measures :
  1. Overall Survival (months) [ Time Frame: 5 months ]
    from the start of Radiotherapy until death / last seen during follow up


Secondary Outcome Measures :
  1. Absolute Basal Gross Tumor Volume (ml) before Radiotherapy (GTV1) [ Time Frame: 5 months ]
    in ml (cc) as detected by initial planning CT or diagnostic CT before the start of RT

  2. Absolute Gross Tumor Volume before Radiation Boost (GTV2) [ Time Frame: 5 months ]
    in ml (cc) as detected in re-planning CT or CBCT before initiation of radiation boost

  3. Relative Gross Tumor Volume Changes (delta GTV related to basal GTV) [ Time Frame: 5 months ]
    percental increase / decrease of GTV in relation to basal GTV1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Locally advanced, inoperable stage III (A and B) non-small-cell lung cancer without prior surgery
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055715


Locations
Show Show 22 study locations
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Radiation Oncology Working Group of the German Cancer Society
Investigators
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Principal Investigator: Christian Ostheimer, MD Klinik fuer Strahlentherapie, Martin-Luther-Universitaet Halle-Wittenberg

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Responsible Party: Christian Ostheimer, MD, MD, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT03055715    
Other Study ID Numbers: ARO 2017-1
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christian Ostheimer, MD, Martin-Luther-Universität Halle-Wittenberg:
NSCLC
Radiotherapy
young DEGRO
tumor volume
lung cancer
radiochemotherapy
prognostic factors
Additional relevant MeSH terms:
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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