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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ursula Nestle, Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
ClinicalTrials.gov Identifier:
NCT00697333
First received: June 11, 2008
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN:

Primary Outcome Measures:
  • local progression free survival [ Time Frame: actuarial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: actuarial ] [ Designated as safety issue: No ]
  • normal tissue toxicity [ Time Frame: actuarial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 394
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697333

Contacts
Contact: U. Nestle, PD 49-761-270 ext 9539 ursula.nestle@uniklinik-freiburg.de
Contact: A. L. Grosu, PhD 49-761-270 ext 9461 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 94630    tanja.schimek-jasch@uniklinik-freiburg.de   
Contact: V. Duncker-Rohr, MD    49-761-270 ext 94630    viola.duncker@uniklinik-freiburg.de   
Principal Investigator: Ursula Nestle, PD         
Universitätsklinikum Freiburg Not yet recruiting
Freiburg i. Br., Baden-Württemberg, Germany, D-79106
Contact: Ursula Nestle, PhD    49-761-270 ext 95390    ursula.nestle@uniklinik-freiburg.de   
Contact: A.-L. Grosu, PhD    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, PhD Universitätsklinikum Freiburg, Germany
  More Information

Additional Information:
Publications:

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
Study First Received: June 11, 2008
Last Updated: January 18, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN:
NSCLC
FDG-PET
Radiotherapy
planning
target volumes

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

ClinicalTrials.gov processed this record on July 29, 2014