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

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ClinicalTrials.gov Identifier: NCT00697333
Recruitment Status : Unknown
Verified July 2016 by Prof. Dr. Ursula Nestle, Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN.
Recruitment status was:  Recruiting
First Posted : June 13, 2008
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ursula Nestle, Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: restriction of radiotherapy to FDG-PET positive areas only Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
Study Start Date : May 2009
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
No Intervention: A
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
Experimental: B
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
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose




Primary Outcome Measures :
  1. time to local progression [ Time Frame: actuarial ]
    Time from randomization to first evidence of local progression or last follow up


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: actuarial ]
    Time from randomization to death or last follow up

  2. normal tissue toxicity [ Time Frame: actuarial ]
    Time from randomization to death or last follow up

  3. in and out field progression [ Time Frame: actuarial ]
    Time from randomization to progression or last follow up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697333


Contacts
Contact: U. Nestle, Prof. 49-761-270 ext 95390 ursula.nestle@uniklinik-freiburg.de
Contact: A. L. Grosu, Prof. 49-761-270 ext 94610 anca.grosu@uniklinik-freiburg.de

Locations
Germany
Universitätsklinikum Freiburg Recruiting
Freiburg i.Br., Baden-Wuerttemberg, Germany, D-79106
Contact: T. Schimek-Jasch, MD    49-761-270 ext 95201    tanja.schimek-jasch@uniklinik-freiburg.de   
Contact: S. Adebahr, MD    49-761-270 ext 95371    sonja.adebahr@uniklinik-freiburg.de   
Principal Investigator: Ursula Nestle, Prof.         
Universitätsklinikum Freiburg Recruiting
Freiburg i. Br., Baden-Württemberg, Germany, D-79106
Contact: Ursula Nestle, Prof.    49-761-270 ext 95390    ursula.nestle@uniklinik-freiburg.de   
Contact: A.-L. Grosu, Prof.    49-761-270 ext 94610    anca.grosu@uniklinik-freiburg.de   
Sponsors and Collaborators
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
Investigators
Principal Investigator: Ursula Nestle, Prof. Universitätsklinikum Freiburg, Germany

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Ursula Nestle, Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg, Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
ClinicalTrials.gov Identifier: NCT00697333     History of Changes
Other Study ID Numbers: AG NUK/RT 2006-1
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Prof. Dr. Ursula Nestle, Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN:
NSCLC
FDG-PET
Radiotherapy
planning
target volumes

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents