Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
NCT ID: NCT00697333
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2009-05-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary endpoint is the local disease control in the chest.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
NCT00083083
The Utility of FDG-PET for Radiation Treatment in NSCLC
NCT00385164
Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers
NCT01421953
Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival
NCT01261598
Tumor Metabolism of Lung Cancer in Patients Who Underwent Percutaneous Radiation Measured With F-18-FDG-PET
NCT00180154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary endpoint is the local disease control in the chest
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Irradiation of all tumor manifestations detectable by CT and/or positron emission tomography using fluoro-deoxy-glucose 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
No interventions assigned to this group
B
Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose including the whole affected lymph node stations by 60 - 74 Gy/2Gy
restriction of radiotherapy to FDG-PET positive areas only
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
restriction of radiotherapy to FDG-PET positive areas only
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* UICC-stage I-III, no resection planned
* complete staging \< 6 wks before treatment including cranial CT
* ECOG \<3, Karnofsky-Index \>60%
* age \> 18 \<
* FEV1 \> 1,0 l or \>35%
* RT-planning according to protocol feasible
* chemotherapy feasible
* written informed consent
Exclusion Criteria
* distant metastases, supraclavicular lymph node metastases
* malignant pleural effusion
* resection of actual tumor performed
* inclusion in other study protocol
* chemotherapy due to actual tumor before FDG-PET
* induction-chemotherapy
* acute vena cava superior syndrome
* second malignancy other than basalioma
* pregnancy, lactation
* heart insufficiency NYHA III/IV
* pneumoconiosis with active inflammatory changes of mediastinal lymph nodes
* acute broncho-pulmonary infection at time of PET-examination
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Ursula Nestle
Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ursula Nestle, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Freiburg, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinikum Freiburg
Freiburg I. Br., Baden-Wurttemberg, Germany
Universitätsklinikum Freiburg
Freiburg i.Br., Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nestle U, Kremp S, Grosu AL. Practical integration of [18F]-FDG-PET and PET-CT in the planning of radiotherapy for non-small cell lung cancer (NSCLC): the technical basis, ICRU-target volumes, problems, perspectives. Radiother Oncol. 2006 Nov;81(2):209-25. doi: 10.1016/j.radonc.2006.09.011. Epub 2006 Oct 24.
Nestle U, Schaefer-Schuler A, Kremp S, Groeschel A, Hellwig D, Rube C, Kirsch CM. Target volume definition for 18F-FDG PET-positive lymph nodes in radiotherapy of patients with non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2007 Apr;34(4):453-62. doi: 10.1007/s00259-006-0252-x. Epub 2006 Oct 21.
Nestle U, Kremp S, Schaefer-Schuler A, Sebastian-Welsch C, Hellwig D, Rube C, Kirsch CM. Comparison of different methods for delineation of 18F-FDG PET-positive tissue for target volume definition in radiotherapy of patients with non-Small cell lung cancer. J Nucl Med. 2005 Aug;46(8):1342-8.
MacManus M, Nestle U, Rosenzweig KE, Carrio I, Messa C, Belohlavek O, Danna M, Inoue T, Deniaud-Alexandre E, Schipani S, Watanabe N, Dondi M, Jeremic B. Use of PET and PET/CT for radiation therapy planning: IAEA expert report 2006-2007. Radiother Oncol. 2009 Apr;91(1):85-94. doi: 10.1016/j.radonc.2008.11.008. Epub 2008 Dec 25.
Nestle U, Weber W, Hentschel M, Grosu AL. Biological imaging in radiation therapy: role of positron emission tomography. Phys Med Biol. 2009 Jan 7;54(1):R1-25. doi: 10.1088/0031-9155/54/1/R01. Epub 2008 Dec 5.
Schaefer A, Kremp S, Hellwig D, Rube C, Kirsch CM, Nestle U. A contrast-oriented algorithm for FDG-PET-based delineation of tumour volumes for the radiotherapy of lung cancer: derivation from phantom measurements and validation in patient data. Eur J Nucl Med Mol Imaging. 2008 Nov;35(11):1989-99. doi: 10.1007/s00259-008-0875-1. Epub 2008 Jul 26.
Craddock M, Nestle U, Koenig J, Schimek-Jasch T, Kremp S, Lenz S, Banfill K, Davey A, Price G, Salem A, Faivre-Finn C, van Herk M, McWilliam A. Cardiac Function Modifies the Impact of Heart Base Dose on Survival: A Voxel-Wise Analysis of Patients With Lung Cancer From the PET-Plan Trial. J Thorac Oncol. 2023 Jan;18(1):57-66. doi: 10.1016/j.jtho.2022.09.004. Epub 2022 Sep 18.
Nestle U, Schimek-Jasch T, Kremp S, Schaefer-Schuler A, Mix M, Kusters A, Tosch M, Hehr T, Eschmann SM, Bultel YP, Hass P, Fleckenstein J, Thieme A, Stockinger M, Dieckmann K, Miederer M, Holl G, Rischke HC, Gkika E, Adebahr S, Konig J, Grosu AL; PET-Plan study group. Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial. Lancet Oncol. 2020 Apr;21(4):581-592. doi: 10.1016/S1470-2045(20)30013-9. Epub 2020 Mar 12.
Nestle U, Rischke HC, Eschmann SM, Holl G, Tosch M, Miederer M, Plotkin M, Essler M, Puskas C, Schimek-Jasch T, Duncker-Rohr V, Ruhl F, Leifert A, Mix M, Grosu AL, Konig J, Vach W. Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process. Eur J Cancer. 2015 Nov;51(17):2525-33. doi: 10.1016/j.ejca.2015.07.036. Epub 2015 Aug 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AG NUK/RT 2006-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.