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Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC

Information source: Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: restriction of radiotherapy to FDG-PET positive areas only (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

Official(s) and/or principal investigator(s):
Ursula Nestle, Prof., Principal Investigator, Affiliation: Universitätsklinikum Freiburg, Germany

Overall contact:
U. Nestle, Prof., Phone: 49-761-270, Ext: 9539, Email: ursula.nestle@uniklinik-freiburg.de

Summary

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.

Clinical Details

Official title: Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: time to local progression

Secondary outcome:

Overall survival

normal tissue toxicity

in and out field progression

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- histologically proved NSCLC

- 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:

- neuroendocrine tumors, plain broncho-alveolar-cell ca.

- 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

Locations and Contacts

U. Nestle, Prof., Phone: 49-761-270, Ext: 9539, Email: ursula.nestle@uniklinik-freiburg.de

Universitätsklinikum Freiburg, Freiburg i.Br., Baden-Wuerttemberg D-79106, Germany; Recruiting
T. Schimek-Jasch, MD, Phone: 49-761-270, Ext: 95201, Email: tanja.schimek-jasch@uniklinik-freiburg.de
S. Adebahr, MD, Phone: 49-761-270, Ext: 95371, Email: viola.duncker@uniklinik-freiburg.de
Ursula Nestle, Prof., Principal Investigator

Universitätsklinikum Freiburg, Freiburg i. Br., Baden-Württemberg D-79106, Germany; Not yet recruiting
Ursula Nestle, Prof., Phone: 49-761-270, Ext: 95390, Email: ursula.nestle@uniklinik-freiburg.de
A.-L. Grosu, Prof., Phone: 49-761-270, Ext: 94610, Email: anca.grosu@uniklinik-freiburg.de

Additional Information

German site of the working group conducting this study

Related publications:

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. Epub 2006 Oct 24. Review.

Nestle U, Schaefer-Schuler A, Kremp S, Groeschel A, Hellwig D, Rübe 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. Epub 2006 Oct 21.

Nestle U, Kremp S, Schaefer-Schuler A, Sebastian-Welsch C, Hellwig D, Rübe 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. Review.

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. Review.

Schaefer A, Kremp S, Hellwig D, Rübe 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.

Starting date: May 2009
Last updated: June 24, 2015

Page last updated: August 23, 2015

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