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Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC (PET-Plan)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
restriction of radiotherapy to FDG-PET positive areas only
Sponsored by
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, FDG-PET, Radiotherapy, planning, target volumes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum FreiburgRecruiting
  • Universitätsklinikum FreiburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A

B

Arm 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

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

Outcomes

Primary Outcome Measures

time to local progression
Time from randomization to first evidence of local progression or last follow up

Secondary Outcome Measures

Overall survival
Time from randomization to death or last follow up
normal tissue toxicity
Time from randomization to death or last follow up
in and out field progression
Time from randomization to progression or last follow up

Full Information

First Posted
June 11, 2008
Last Updated
July 13, 2016
Sponsor
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
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1. Study Identification

Unique Protocol Identification Number
NCT00697333
Brief Title
Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
Acronym
PET-Plan
Official Title
Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, FDG-PET, Radiotherapy, planning, target volumes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm 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
Arm Title
B
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
restriction of radiotherapy to FDG-PET positive areas only
Intervention Description
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose
Primary Outcome Measure Information:
Title
time to local progression
Description
Time from randomization to first evidence of local progression or last follow up
Time Frame
actuarial
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from randomization to death or last follow up
Time Frame
actuarial
Title
normal tissue toxicity
Description
Time from randomization to death or last follow up
Time Frame
actuarial
Title
in and out field progression
Description
Time from randomization to progression or last follow up
Time Frame
actuarial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
U. Nestle, Prof.
Phone
49-761-270
Ext
95390
Email
ursula.nestle@uniklinik-freiburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
A. L. Grosu, Prof.
Phone
49-761-270
Ext
94610
Email
anca.grosu@uniklinik-freiburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Nestle, Prof.
Organizational Affiliation
Universitätsklinikum Freiburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Freiburg
City
Freiburg i.Br.
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
D-79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T. Schimek-Jasch, MD
Phone
49-761-270
Ext
95201
Email
tanja.schimek-jasch@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
S. Adebahr, MD
Phone
49-761-270
Ext
95371
Email
sonja.adebahr@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Ursula Nestle, Prof.
Facility Name
Universitätsklinikum Freiburg
City
Freiburg i. Br.
State/Province
Baden-Württemberg
ZIP/Postal Code
D-79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Nestle, Prof.
Phone
49-761-270
Ext
95390
Email
ursula.nestle@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
A.-L. Grosu, Prof.
Phone
49-761-270
Ext
94610
Email
anca.grosu@uniklinik-freiburg.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
17064802
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.
Results Reference
background
PubMed Identifier
17058078
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.
Results Reference
background
PubMed Identifier
16085592
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.
Results Reference
background
PubMed Identifier
19100641
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.
Results Reference
background
PubMed Identifier
19060363
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.
Results Reference
background
PubMed Identifier
18661128
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.
Results Reference
background
PubMed Identifier
32171429
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.
Results Reference
derived
PubMed Identifier
26277100
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.
Results Reference
derived

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

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