Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung. STRICT-LUNG & STAR-LUNG STUDY

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.

• ECOG performance status ≤ 2.

• Age \> 18 years old. • Life expectancy \> 6 months.

• Maximum one central tumor with the diameter ≤ 5 cm or \> 1 adjacent located tumors with a summarized diameter (measured from the outer margin from one tumor to the outer margin of the other) of maximum 5 cm on a diagnostic CT-scan.

• Medically inoperable or refused surgery.

• The central tumors must be localized within or touching the 2.5 cm-zone of the PBT, or within 0.5 cm from the spinal cord, esophagus or heart. Evaluation is primarily performed on the diagnostic CT scan

• All metastatic sites are treated or planned for ablative therapy (including surgery). For oligo-progressive disease (OPD), only the sites in progression are required to fulfil this criterion

• Adequate lung function to tolerate treatment, at the discretion of the treating physician. • Ability to understand and willingness to sign a written informed consent document. • Patient must be accessible to treatment 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 effective contraception for the duration of study treatment and one month thereafter.

• Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of the trachea, main bronchi or intermediate bronchus. Evaluation is primarily performed on the diagnostic CT scan

• Patients with other non-central tumors synchronous with the central lesion may be included and treated with SBRT in respect to local practice.

• A baseline PET/CT scan within 2 months of inclusion.

• An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide.

Locations
Other Locations
Denmark
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Herlev University Hospital
RECRUITING
Herlev
Odense University Hospital
RECRUITING
Odense
Department of Oncology, Lillebaelt Hospital
RECRUITING
Vejle
Contact Information
Primary
Mette Pøhl, MD, PhD
mette.poehl@regionh.dk
+4535451824
Backup
Lone Hoffmann, Ass. Prof, MSc, PhD
lone.hoffmann@aarhus.rm.dk
+4529939779
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2033-05-01
Participants
Target number of participants: 138
Treatments
Experimental: STRICT LUNG
Central Tumors in the Lung The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located \<0.5 cm from the spinal cord, heart and aorta.
Experimental: STAR LUNG
Ultra-Centrally Tumors in the Lung Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment).
Related Therapeutic Areas
Sponsors
Collaborators: University of Copenhagen, Odense University Hospital, Aalborg University Hospital, Vejle Hospital, Aarhus University Hospital
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov