NCT03742687Recruiting
Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Source: ClinicalTrials.gov · Last updated 11 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 151 (estimated)
- First submitted
- 11 Oct 2017
- Start date
- 22 Nov 2018
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Danish Lung Cancer Group
- Diseases
- Lung cancer
- NCT number
- NCT03742687
What you commit to
- Study type: Interventional
- Planned participants: 151
- From 22 Nov 2018 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.
Other illness
- Uncontrolled metastatic disease.
- Other active malignant disease.
Other
- Dose plan conforming to protocol planning criteria not possible.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.