Clinical trial · Interventional
Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
NCT00697333CI-TRIAL-00023061PET-PlanunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| restriction of radiotherapy to FDG-PET positive areas only | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A
- description
- 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
- type
- EXPERIMENTAL
- label
- B
- description
- 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
- interventionNames
- Procedure: restriction of radiotherapy to FDG-PET positive areas only
Primary outcomes (1)
- measure
- time to local progression
- timeFrame
- actuarial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDNestle 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. PMID 17064802
- BACKGROUNDNestle 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. PMID 17058078
- BACKGROUNDNestle 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. PMID 16085592
- BACKGROUNDMacManus 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. PMID 19100641
- BACKGROUNDNestle 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. PMID 19060363
- BACKGROUNDSchaefer 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.