NCT00697333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

7.5 years

First QC Date

June 11, 2008

Last Update Submit

July 13, 2016

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLCFDG-PETRadiotherapyplanningtarget volumes

Outcome Measures

Primary Outcomes (1)

  • time to local progression

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

    actuarial

Secondary Outcomes (3)

  • Overall survival

    actuarial

  • normal tissue toxicity

    actuarial

  • in and out field progression

    actuarial

Study Arms (2)

A

NO INTERVENTION

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

B

EXPERIMENTAL

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

Procedure: restriction of radiotherapy to FDG-PET positive areas only

Interventions

restriction of radiotherapy to FDG-PET positive areas onlyPROCEDURE

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Freiburg

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

RECRUITING

Universitätsklinikum Freiburg

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

RECRUITING

Related Publications (9)

  • 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.

    PMID: 17064802BACKGROUND

  • 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.

    PMID: 17058078BACKGROUND

  • 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.

    PMID: 16085592BACKGROUND

  • 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.

    PMID: 19100641BACKGROUND

  • 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.

    PMID: 19060363BACKGROUND

  • 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.

    PMID: 18661128BACKGROUND

  • 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.

    PMID: 36130693DERIVED

  • 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.

    PMID: 32171429DERIVED

  • 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.

    PMID: 26277100DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ursula Nestle, Prof.

    Universitätsklinikum Freiburg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

U. Nestle, Prof.

CONTACT

49-761-270ursula.nestle@uniklinik-freiburg.de

A. L. Grosu, Prof.

CONTACT

49-761-270anca.grosu@uniklinik-freiburg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

May 1, 2009

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

July 14, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

DE(2)