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Non-small Cell Lung CancerPhase 2PET-PlanNCT00697333

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

A Phase 2 study testing restriction of radiotherapy to FDG-PET positive areas only in people with Non-small Cell Lung Cancer, run by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
restriction of radiotherapy to FDG-PET positive areas only
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesGermany
Study dates
May 2009to May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 17Show fewer
  • RT-planning according to protocol feasible
  • chemotherapy feasible
  • written informed consent
  • 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

Who cannot join

  • neuroendocrine tumors, plain broncho-alveolar-cell ca.
  • distant metastases, supraclavicular lymph node metastases
  • malignant pleural effusion
  • resection of actual tumor performed

Trial locations and contacts

2 sites in 1 country.

U. Nestle, Prof. contact

49-761-270 ext. 95390

ursula.nestle@uniklinik-freiburg.de

A. L. Grosu, Prof. contact

49-761-270 ext. 94610

anca.grosu@uniklinik-freiburg.de

Germany2 sites, 2 recruiting

  • Universitätsklinikum Freiburg

    Freiburg I. Br., Baden-Wurttemberg, D-79106

    Ursula Nestle, Prof., 49-761-270 ext. 95390, ursula.nestle@uniklinik-freiburg.de

    A.-L. Grosu, Prof., 49-761-270 ext. 94610, anca.grosu@uniklinik-freiburg.de

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg i.Br., Baden-Wurttemberg, D-79106

    T. Schimek-Jasch, MD, 49-761-270 ext. 95201, tanja.schimek-jasch@uniklinik-freiburg.de

    S. Adebahr, MD, 49-761-270 ext. 95371, sonja.adebahr@uniklinik-freiburg.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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

Being tested
restriction of radiotherapy to FDG-PET positive areas only
Keywords
NSCLC, FDG-PET, Radiotherapy, planning, target volumes
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • restriction of radiotherapy to FDG-PET positive areas onlyProcedure or surgery

    Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose

Study groups in NCT00697333
Study groupRoleWhat they receive
ANo interventionIrradiation 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
BExperimentalIrradiation 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
Receives: Procedure: restriction of radiotherapy to FDG-PET positive areas only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to local progression

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

    Measured: actuarial

Secondary outcomes (3)

  1. Overall survival

    Time from randomization to death or last follow up

    Measured: actuarial

  2. normal tissue toxicity

    Time from randomization to death or last follow up

    Measured: actuarial

  3. in and out field progression

    Time from randomization to progression or last follow up

    Measured: actuarial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2016 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697333
Sponsor's protocol ID
AG NUK/RT 2006-1
Acronym
PET-Plan
Status last verified
Jul 2016
First submitted
11 Jun 2008
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

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. doi: 10.1016/j.radonc.2006.09.011. Epub 2006 Oct 24.

    PubMed 17064802

  • 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.

    PubMed 17058078

  • 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.

    PubMed 16085592

  • 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.

    PubMed 19100641

  • 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.

    PubMed 19060363

  • 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.

    PubMed 18661128

  • Gkika E, Dejonckheere CS, Sahlmann J, Barth SA, Schimek-Jasch T, Adebahr S, Hecht M, Miederer M, Brose A, Binder H, Konig J, Grosu AL, Nestle U, Rimner A. Impact of mediastinal tumor burden and lymphatic spread in locally advanced non-small-cell lung cancer: A secondary analysis of the multicenter randomized PET-Plan trial. Radiother Oncol. 2024 Nov;200:110521. doi: 10.1016/j.radonc.2024.110521. Epub 2024 Sep 3.

    PubMed 39236984

  • Craddock M, Nestle U, Koenig J, Schimek-Jasch T, Kremp S, Lenz S, Banfill K, Davey A, Price G, Salem A, Faivre-Finn C, van Herk M, McWilliam A. Cardiac Function Modifies the Impact of Heart Base Dose on Survival: A Voxel-Wise Analysis of Patients With Lung Cancer From the PET-Plan Trial. J Thorac Oncol. 2023 Jan;18(1):57-66. doi: 10.1016/j.jtho.2022.09.004. Epub 2022 Sep 18.

    PubMed 36130693

  • 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.

    PubMed 32171429

  • 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.

    PubMed 26277100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing restriction of radiotherapy to FDG-PET positive areas only in people with Non-small Cell Lung Cancer, run by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact U. Nestle, Prof. (49-761-270 ext. 95390, ursula.nestle@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to local progression (time frame: actuarial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00697333, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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