Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05354596

Stereotactic Radiation Therapy for Centrally and Ultra-centrally Located Lung Tumors STRICT-LUNG & STAR-LUNG Study

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

138

Participants Needed

6

Research Sites

382 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

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

Eligible

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.
Not Eligible

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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Daily treatment sessions over a short period as determined by clinical protocol

Participants receive stereotactic body radiation therapy targeting centrally or ultra-centrally located lung tumors with daily image-guided plan adaptation.

Daily visits for treatment sessions

Follow-up

Duration - Up to 10 years

Participants are monitored for treatment-related adverse events, quality of life, tumor control, and survival outcomes for up to 10 years after treatment.

Regular visits at treatment end, 4-6 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months, and annually up to 10 years

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

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Research Team

M

Mette Pøhl, MD, PhD

L

Lone Hoffmann, Ass. Prof, MSc, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours.

L Hoffmann, G F Persson, L Nygård...

https://pubmed.ncbi.nlm.nih.gov/35421513