NCT03742687 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
| NCT ID | NCT03742687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Lung Cancer Group |
| Condition | Stage III Non-small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 151 participants |
| Start Date | 2018-11-22 |
| Primary Completion | 2023-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 151 participants in total. It began in 2018-11-22 with a primary completion date of 2023-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Azza A Khalil, MD, PhD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT03742687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage III Non-small-cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03742687 currently recruiting?
Yes, NCT03742687 is actively recruiting participants. Contact the research team at azzakhal@rm.dk for enrollment information.
Where is the NCT03742687 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT03742687 clinical trial?
NCT03742687 is sponsored by Danish Lung Cancer Group. The principal investigator is Azza A Khalil, MD, PhD at Aarhus University Hospital. The trial plans to enroll 151 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.