An interventional study of Escalated: Inhomogeneous dose plan and Standard: Homogeneous dose plan in NSCLC, sponsored by Olfred Hansen. Recruiting at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Olfred Hansen · Not applicable, Interventional, and Treatment
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.
Olfred Hansen is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment will be given over 33 treatments. The dose is 66 Gy.
Radiation: Standard: Homogeneous 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
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.
Time frame: 5-7 years
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
Time frame: 10 years
Survival
Time from randomization to exact date of death of any cause.
Time frame: 15 years
Progression free survival
Time from randomization to date of progression, death, or occurence of metastatic disease
Time frame: 15 years
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Olfred Hansen