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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03055715
Date of registration: 14/02/2017
Prospective Registration: Yes
Primary sponsor: Martin-Luther-Universität Halle-Wittenberg
Public title: Prognostic Evaluation of Tumor Volume and Its Changes in Radical Radiotherapy of Advanced NSCLC
Scientific title: Multicentric Retrospective Prognostic Evaluation of Tumor Volume and Their Change in the Curative-intended, Radical Radiotherapy of Locally Advanced NSCLC
Date of first enrolment: April 1, 2017
Target sample size: 346
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03055715
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Austria Belgium Germany Spain Switzerland
Contacts
Name:     Christian Ostheimer, MD
Address: 
Telephone:
Email:
Affiliation:  Klinik fuer Strahlentherapie, Martin-Luther-Universitaet Halle-Wittenberg
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Non Small Cell Lung Cancer Stage III
Intervention(s)
Primary Outcome(s)
Overall Survival (months) [Time Frame: 5 months]
Secondary Outcome(s)
Absolute Gross Tumor Volume before Radiation Boost (GTV2) [Time Frame: 5 months]
Relative Gross Tumor Volume Changes (delta GTV related to basal GTV) [Time Frame: 5 months]
Absolute Basal Gross Tumor Volume (ml) before Radiotherapy (GTV1) [Time Frame: 5 months]
Secondary ID(s)
ARO 2017-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Radiation Oncology Working Group of the German Cancer Society
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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