Actively Recruiting
A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).
Led by Rigshospitalet, Denmark · Updated on 2023-03-03
138
Participants Needed
6
Research Sites
547 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.
- ECOG performance status of 2 or less.
- Age over 18 years old.
- Life expectancy greater than 6 months.
- Maximum one central tumor with diameter 5 cm or less, or multiple adjacent tumors with combined diameter 5 cm or less on CT scan.
- Medically inoperable or refused surgery.
- Central tumors located within or touching 2.5 cm zone of pulmonary bronchial tree or within 0.5 cm from spinal cord, esophagus, or heart.
- All metastatic sites treated or planned for ablative therapy; for oligo-progressive disease, only sites in progression must meet this.
- Adequate lung function to tolerate treatment, per physician's judgment.
- Ability to understand and willingness to sign informed consent.
- Accessible to treatment and follow-up procedures.
- Fertile women must have negative pregnancy test and use effective contraception; fertile men and women must use contraception during treatment and one month after.
- Ultra-central tumors located within 0.0 to 0.5 cm zone of trachea, main bronchi, or intermediate bronchus.
- Patients with other non-central tumors synchronous with central lesion may be included and treated with SBRT.
- Baseline PET/CT scan within 2 months prior to inclusion.
- Ablative treatment strategy deemed clinically relevant by treating physician.
You will not qualify if you...
- Tumor with intra-bronchial or intra-tracheal growth based on imaging or endoscopy.
- Previous radiotherapy at radiation site exceeding dose constraints as judged by physician.
- Unable to tolerate physical setup required for SBRT.
- Uncontrolled intercurrent illness.
- Pregnancy.
- Participation in another interventional study.
- For STAR-LUNG patients, lack of MR compatibility due to pacemaker, metal implants, or similar devices.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9100
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Herlev University Hospital
Herlev, Denmark, 2730
Actively Recruiting
5
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
6
Department of Oncology, Lillebaelt Hospital
Vejle, Denmark, 7100
Actively Recruiting
Research Team
M
Mette Pøhl, MD, PhD
CONTACT
L
Lone Hoffmann, Ass. Prof, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here