Actively Recruiting
HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Led by Danish Lung Cancer Group · Updated on 2023-09-11
151
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
D
Danish Lung Cancer Group
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) who cannot undergo the standard chemoradiotherapy due to either extensive tumor size or fragile health. These patients usually have limited options and are often given only palliative care. The study focuses on assessing the safety and effectiveness of a heterogeneously hypofractionated radiotherapy schedule designed to improve local disease control and survival while reducing toxicity compared to standard long-course treatments. Patients will receive a specialized radiotherapy plan that delivers higher doses to the central tumor and bulky lymph nodes while lowering exposure to surrounding healthy tissue. The treatment consists of 24 radiation sessions administered five days a week, allowing a shorter overall schedule than the conventional 33 fractions. Some participants may also receive chemotherapy or targeted therapy based on their genetic mutations. Patients are grouped into two categories: those with large target volumes unsuitable for standard dosing and those too fragile for longer treatment courses. During the study, participants will undergo regular imaging scans, lung function tests, and cardiac monitoring to track treatment effects and detect any recurrences. Follow-up visits occur every three months for two years, then every six months afterward. Researchers will measure overall survival after 12 months as the primary outcome, along with time to local disease failure and incidence of treatment-related side effects up to 60 months. Safety is closely monitored throughout, including reporting of serious adverse events related to thoracic organs.
CONDITIONS
Brief Title
Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced, inoperable non-small cell lung cancer (NSCLC).
- Age 18 years or older.
- Signed informed consent form.
- Performance status between 0 and 2.
- Ability to comply with study and follow-up procedures.
- Fertile women must have a negative pregnancy test and use effective contraception during treatment and for one month afterward.
- Fertile men and women must use effective contraception during the study treatment and one month thereafter.
You will not qualify if you...
- Prior radiotherapy to the chest unless there is no significant overlap with current treatment areas.
- Inability to create a dose plan that meets the study criteria.
- Uncontrolled metastatic disease.
- Presence of other active malignant diseases.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 5 weeks
Participants receive heterogeneously hypofractionated radiotherapy for locally advanced NSCLC, delivered in 24 fractions over approximately 5 weeks, with daily imaging for treatment position verification. Some participants may receive 1-2 cycles of induction chemotherapy or targeted therapy according to local guidelines before or during radiotherapy.
5 visits per week for up to 5 weeks (in-person)
Duration - Up to 48 months after treatment
Participants are monitored for treatment outcomes and side effects. Follow-up visits include CT scans every 3 months for the first 24 months, then every 6 months thereafter. Lung function tests and ECG are performed at baseline and during follow-up as needed. Adverse events and toxicity are assessed throughout follow-up.
Visits every 3 months for 24 months, then every 6 months until study end (in-person)
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
Research Team
A
Azza A Khalil, MD, PhD
M
Marianne M Knap, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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