Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®
NCT ID: NCT02354274
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2015-01-31
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard: Homogeneous dose plan
Treatment will be given over 33 treatments. The dose is 66 Gy.
Standard: Homogeneous dose plan
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
Escalated: Inhomogeneous dose plan
Interventions
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Escalated: Inhomogeneous dose plan
Standard: Homogeneous dose plan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Vejle Hospital
OTHER
Naestved Hospital
OTHER
Aalborg University Hospital
OTHER
Herlev Hospital
OTHER
Olfred Hansen
OTHER
Responsible Party
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Olfred Hansen
MD
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev University Hospital
Herlev, , Denmark
Department of Oncology, Naestved Hospital
Næstved, , Denmark
Department of Oncology, Odense University Hospital
Odense, , Denmark
Department of Oncology, Vejle Hospital
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Svetlana Kunwald, MD
Role: primary
Marianne M. Knap, MD
Role: primary
Gitte F. Persson, MD
Role: primary
Jon L. Andersen, MD
Role: primary
Christa Haugaard, MD
Role: primary
References
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Schytte T, Knap MM, Kristiansen C, Appelt AL, Khalil A, Peucelle C, Lutz CM, Moller DS, Sande EPS, Sundby F, Persson G, Schmidt H, Land LH, Rogg L, Pohl M, Lund MD, Nielsen M, Levin N, Hansen O, Thing RS, Borissova S, Halvorsen T, Nielsen TB, Hansen TS, Haakensen VD, Ottosson W, Brink C, Hoffmann L. Toxicity Within 6 Months of Heterogeneous Fluorodeoxyglucose-Guided Radiotherapy Dose Escalation for Locally Advanced Non-Small Cell Lung Cancer in the Scandinavian Randomized Phase III NARLAL2 Trial. J Clin Oncol. 2025 Jun 10;43(17):1972-1983. doi: 10.1200/JCO-24-01386. Epub 2025 Apr 18.
Other Identifiers
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NARLAL 2
Identifier Type: -
Identifier Source: org_study_id
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