RecruitingNot ApplicableNCT03742687

Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

Sponsor

Danish Lung Cancer Group

Enrollment

151 participants

Start Date

Nov 22, 2018

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Side Effect Stage IV Non-Small Cell Lung Cancer Stage III Non-small Cell Lung Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a type of radiation treatment called heterogeneously hypofractionated radiotherapy — a technique that delivers higher radiation doses to areas with more cancer and lower doses to other areas — for people with locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. **You may be eligible if...** - You have non-small cell lung cancer (NSCLC) confirmed by biopsy or cell analysis - Your cancer is locally advanced and cannot be removed by surgery - You are 18 years or older - Your overall health is reasonably good (performance status 0–2) - You are able to attend follow-up appointments - If you could become pregnant, you use effective contraception and test negative for pregnancy **You may NOT be eligible if...** - Your lung cancer is a small cell type - Your cancer has spread to distant organs (metastatic) - You are unable to receive radiation due to prior treatment or health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHeterogeneously Hypofractionated Radiotherapy

A heterogeneous hypofractionated schedule for the treatment of high-risk locally advanced NSCLC patients in which the central idea is to decrease dose to normal tissue by ascribing a heterogeneous dose to the PTV. The dose to the periphery of the PTV as well as to the majority of lymph node targets is decreased compared to a standard treatment. The gross volume of the primary tumour and bulky lymph nodes receive mean doses of up to 66 Gy in 24 fractions, and thus receive a hypofractionated higher biological effective dose than standard 66 Gy in 33 fractions.

Locations(1)

Aarhus University Hospital

Aarhus, Denmark

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NCT03742687

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