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Sponsored by: |
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN |
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Information provided by: | Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN |
ClinicalTrials.gov Identifier: | NCT00697333 |
Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.
Primary endpoint is the local disease control in the chest.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Procedure: restriction of radiotherapy to FDG-PET positive areas only |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET |
Estimated Enrollment: | 394 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention
Irradiation of all tumor manifestations detectable by CT and/or FDG-PET including a part of eventual atelectasis and the whole affected lymph node stations by 60 - 74 Gy/2Gy) irradiation of elective lymph node stations up to 50 Gy/2 Gy
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B: Experimental
Irradiation of all tumor manifestations detectable by FDG-PET including the whole affected lymph node stations by 60 - 74 Gy/2Gy
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Procedure: restriction of radiotherapy to FDG-PET positive areas only
Restriction of target volumes to FDG-positive areas
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: U. Nestle, PD | 49-684-1162 ext 2201 | raunes@uks.eu |
Contact: A. L. Grosu, PhD | 49-761-270 ext 9461 | anca.grosu@uniklinik-freiburg.de |
Germany, Baden-Württemberg | |
Universitätsklinikum Freiburg | |
Freiburg i. Br., Baden-Württemberg, Germany, D-79106 | |
Germany, Saarland | |
Universitätsklinikum des Saarlandes | |
Homburg/Saar, Saarland, Germany, D-66421 |
Principal Investigator: | Ursula Nestle, PhD | Universitätsklinikum des Saarlandes, Homburg/Saar, Germany |
Responsible Party: | Universitätsklinikum des Saarlandes ( PD Dr. Ursula Nestle ) |
Study ID Numbers: | AG NUK/RT 2006-1 |
Study First Received: | June 11, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00697333 |
Health Authority: | Germany: Ethics Commission |
NSCLC FDG-PET Radiotherapy planning target volumes |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |