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

Non-small Cell Lung Cancer Clinical Trial

— PET-Plan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00697333
• Other study ID #: AG NUK/RT 2006-1
• Status: Recruiting
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: July 13, 2016
• Start date: May 2009
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
• Contact: U. Nestle, Prof.
• Phone: 49-761-270
• Email: ursula.nestle[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• restriction of radiotherapy to FDG-PET positive areas only
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg i. Br.	Baden-Württemberg
Germany	Universitätsklinikum Freiburg	Freiburg i.Br.	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. Epub 2006 Oct 24. Review. — View Citation

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. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to local progression	Time from randomization to first evidence of local progression or last follow up	actuarial	No
Secondary	Overall survival	Time from randomization to death or last follow up	actuarial	No
Secondary	normal tissue toxicity	Time from randomization to death or last follow up	actuarial	Yes
Secondary	in and out field progression	Time from randomization to progression or last follow up	actuarial	No

External Links

•   German site of the working group conducting this study