What is this trial studying for lung tumors?

This trial is studying stereotactic body radiation therapy (SBRT) to treat centrally and ultra-centrally located lung tumors. Researchers want to learn about the safety, side effects, and tumor control of this radiation treatment over time. The study is sponsored by Rigshospitalet, Denmark, and aims to improve treatment options for these difficult tumor locations.

Who may be eligible for this lung tumor clinical trial?

Adults aged 18 or older with non-hematological cancer or known cancer with local progression may be eligible. Participants must have a certain performance status, a limited tumor size in the lung, and be able to tolerate radiation therapy and follow-up. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this lung tumor clinical trial?

Study-related care, including the study radiation therapy and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered during participation.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05354596

Phase II Study of Targeted Stereotactic Radiation for Centrally and Ultra-Centrally Located Lung Tumors Using Standard and MR-Guided Techniques

Led by Rigshospitalet, Denmark · Updated on 2023-03-03

138

Participants Needed

Research Sites

382 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effectiveness of stereotactic body radiation therapy SBRT in treating centrally and ultra-centrally located lung tumors. The study involves patients with primary, oligo-metastatic, or oligo-progressive non-hematological cancers, focusing on tumor control, treatment-related side effects, quality of life, and survival outcomes. It aims to improve understanding and future treatment strategies for these challenging tumor locations. Patients with centrally located lung tumors receive SBRT using standard linear accelerators with daily cone beam CT image-guidance and plan adaptation, while those with ultra-centrally located tumors are treated on MR-linac machines with daily MR-guided plan adaptation. Central tumors are defined by proximity to specific airways and organs, and ultra-central tumors are even closer to critical structures. Tumor location and suitability are assessed by diagnostic imaging, and treatment plans are adapted daily to target tumors precisely. Participants will be monitored extensively, with treatment-related adverse events recorded from baseline through up to 10 years post-treatment at multiple intervals. Follow-up includes imaging scans and clinical assessments to measure tumor control, disease progression, and survival. Quality of life is also assessed. The study enrollment continues until target patient numbers are met, allowing detailed long-term evaluation of treatment outcomes and safety for both tumor groups.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.
ECOG performance status 2 or less.
Age over 18 years.
Life expectancy greater than 6 months.
Maximum one central tumor with diameter 5 cm or less, or multiple adjacent tumors with a combined diameter up to 5 cm on diagnostic CT.
Medically inoperable or refused surgery.
Central tumors located within or touching 2.5 cm zone of PBT, 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 progressing sites must meet this.
Adequate lung function to tolerate treatment as decided by treating physician.
Ability to understand and willingness to sign informed consent.
Patient accessible to treatment and follow-up procedures.
Fertile women must have negative pregnancy test.
Fertile men and women must use effective contraception during treatment and one month thereafter.
Ultra-centrally located tumors within 0.0 to 0.5 cm of trachea, main bronchi, or intermediate bronchus.
Patients with other non-central tumors synchronous with central lesion may be included and treated per local practice.
Baseline PET/CT scan within 2 months of inclusion.
Ablative strategy deemed clinically relevant by treating physician.

You will not qualify if you...

Tumor with intra-bronchial or intra-tracheal growth as seen on imaging or endoscopy.
Previous radiotherapy with combined dose at site exceeding dose constraints as judged by treating physician.
Patient unable to tolerate physical setup required for SBRT.
Uncontrolled intercurrent illness.
Pregnancy.
Participation in another interventional study.
For ultra-centrally located tumor patients, lack of MR compatibility due to pacemaker, steel implants, or similar.

Research Team

Mette Pøhl, MD, PhD

Lone Hoffmann, Ass. Prof, MSc, PhD

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