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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.