HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Azza A Khalil, MD, PhD
azzakhal@rm.dk
+4578462556
Backup
Marianne M Knap, MD, PhD
mariknap@rm.dk
+4578462556
Time Frame
Start Date: 2018-11-22
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 151
Treatments
Experimental: A:Large target volume
The target volume for radiotherapy treatment volume is considered too large for a standard treatment of 66Gy in 33 fractions, considering the expected normal tissue toxicity with a standard treatment plan. Heterogeneously Hypofractionated Radiotherapy plan ( 24 fractions )
Experimental: B:Fragile patient
The patient is too fragile for standard long-course radiotherapy with 66 Gy. Heterogeneously Hypofractionated Radiotherapy plan ( 24 fractions )
Sponsors
Leads: Danish Lung Cancer Group
Collaborators: Odense University Hospital, Vejle Hospital, Herlev Hospital, Aarhus University Hospital, Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov