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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Vejle Hospital |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard: Homogeneous dose plan | Active Comparator | Treatment will be given over 33 treatments. The dose is 66 Gy. |
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| Escalation: Inhomogeneous dose plan | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escalated: Inhomogeneous dose plan | Radiation |
| ||
| Standard: Homogeneous dose plan |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen) | 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. | 5-7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity (graded after CTCAE 4.0 assessed by physician) | Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits | 10 years |
| Survival | Time from randomization to exact date of death of any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olfred Hansen, MD | Contact | +4565411867 | olfred.hansen@rsyd.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Not yet recruiting | Aalborg | 9100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40249893 | Derived | 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. |
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| OTHER |
| Naestved Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Herlev Hospital | OTHER |
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Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.
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| Radiation |
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| 15 years |
| Progression free survival | Time from randomization to date of progression, death, or occurence of metastatic disease | 15 years |
| Aarhus University Hospital | Recruiting | Aarhus | 8000 | Denmark |
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| Rigshospitalet | Not yet recruiting | Copenhagen | 2100 | Denmark |
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| Herlev University Hospital | Recruiting | Herlev | 2730 | Denmark |
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| Department of Oncology, Naestved Hospital | Not yet recruiting | Næstved | Denmark |
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| Department of Oncology, Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| Department of Oncology, Vejle Hospital | Recruiting | Vejle | 7100 | Denmark |
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