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Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®

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ClinicalTrials.gov Identifier: NCT02354274
Recruitment Status : Recruiting
First Posted : February 3, 2015
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Vejle Hospital
Naestved Hospital
Aalborg University Hospital
Herlev Hospital
Information provided by (Responsible Party):
Olfred Hansen, Odense University Hospital

Brief Summary:
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread

Condition or disease Intervention/treatment Phase
NSCLC Radiation: Escalated: Inhomogeneous dose plan Radiation: Standard: Homogeneous dose plan Not Applicable

Detailed Description:
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.
Primary Purpose: Treatment
Official Title: Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
Actual Study Start Date : January 2015
Estimated Primary Completion Date : October 2029
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard: Homogeneous dose plan
Treatment will be given over 33 treatments. The dose is 66 Gy.
Radiation: Standard: Homogeneous dose plan
Experimental: Escalation: Inhomogeneous dose plan

Radiation dose is increased to tumor and lymph nodes based on an inhomogeneous dose distribution determined by the most active ( FDG-PET criteria ) area of the node compared to a standard uniform dose distribution.

Treatment will be given over 33 treatments. The dose is as high as possible taking the tolerance of the normal tissue into consideration

Radiation: Escalated: Inhomogeneous dose plan



Primary Outcome Measures :
  1. Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen) [ Time Frame: 5-7 years ]
    Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse.


Secondary Outcome Measures :
  1. Toxicity (graded after CTCAE 4.0 assessed by physician) [ Time Frame: 10 years ]
    Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits

  2. Survival [ Time Frame: 15 years ]
    Time from randomization to exact date of death of any cause.

  3. Progression free survival [ Time Frame: 15 years ]
    Time from randomization to date of progression, death, or occurence of metastatic disease



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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:

  • Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
  • Performance status 0-1
  • Able to comply with treatment and follow study and follow-up procedures
  • Women must have negative pregnancy test
  • Signed, informed consent
  • Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available

Exclusion Criteria:

  • Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
  • Need for nasal oxygen
  • Former thoracic radiotherapy, unless there is no significant overlap with previous fields
  • Any other active malignant disease
  • Unable to take oral medications or needing intravenous nutrition
  • Ulcer
  • Nursing women

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): NCT02354274


Contacts
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Contact: Olfred Hansen, MD +4565411867 olfred.hansen@rsyd.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9100
Contact: Svetlana Kunwald, MD         
Principal Investigator: Svetlana Kunwald, MD         
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Marianne M. Knap, MD         
Principal Investigator: Marianne M. Knap, MD         
Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Gitte F. Persson, MD         
Herlev University Hospital Recruiting
Herlev, Denmark, 2730
Contact: Jon L. Andersen, MD         
Principal Investigator: Jon L. Andersen, MD         
Department of Oncology, Naestved Hospital Not yet recruiting
Naestved, Denmark
Contact: Kim Wederwang, MD       kwd@regionsjaelland.dk   
Principal Investigator: Kim Wedervang, MD         
Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Olfred Hansen, MD    +45 6541 1867    olfred.hansen@rsyd.dk   
Principal Investigator: Olfred Hansen, MD         
Sub-Investigator: Tine Schytte, MD         
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Christa Haugaard, MD         
Principal Investigator: Christa Haugaard, MD         
Sponsors and Collaborators
Olfred Hansen
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Vejle Hospital
Naestved Hospital
Aalborg University Hospital
Herlev Hospital
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Responsible Party: Olfred Hansen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02354274    
Other Study ID Numbers: NARLAL 2
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020