Clinical trial NCT00697333: Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
Official title: Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
FDG-PET
Radiotherapy
planning
target volumes
Lead sponsor: Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: time to local progression
timeFrame: actuarial
Secondary outcomes:
measure: Overall survival
timeFrame: actuarial
measure: normal tissue toxicity
timeFrame: actuarial
measure: in and out field progression
timeFrame: actuarial
Other outcomes:
Locations:
city: Freiburg i.Br.
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Wuerttemberg
city: Freiburg i. Br.
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
Study officials:
affiliation: Universitätsklinikum Freiburg, Germany
name: Ursula Nestle, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.