Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Recruiting · NCT03742687 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment. The aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).
Who can take part
Inclusion criteria
- Histologically or cytological confirmed locally advanced, inoperable NSCLC.
- Age ≥18 years.
- Signed informed consent.
- Performance status 0-2.
- Able to comply with study and follow-up procedures.
- Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter.
Exclusion criteria
- Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.
- Dose plan conforming to protocol planning criteria not possible.
- Uncontrolled metastatic disease.
- Other active malignant disease.
Where it is running
1 location listed.
- Aarhus University Hospital - Aarhus, Denmark