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). (STRICTSTARLUNG)

March 1, 2023 updated by: Mette Pøhl, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The STRICT-LUNG study will evaluate the feasibility and safety of daily image-guided SBRT in centrally located lung tumors (primary, oligo-metastatic or oligo-progressive). The STAR-LUNG study will evaluate the feasibility and safety of daily adaptive MR-linac based SBRT in ultra-centrally located lung tumors (primary, oligo-metastatic or oligo-progressive).

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.

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).

The main purposes are to evaluate the feasibility, safety and efficacy of stereotactic radiation to centrally and ultra-centrally located tumors, including treatment related adverse events, quality of life (QoL) assessments, local tumor control rate, disease free survival, and overall survival and facilitate future stratification of this patient group for definitive treatment.

Treatment related adverse events (TRAE) will be registered at baseline, end of treatment, 4-6 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after treatment, and hereafter every year until 10th year of follow-up.

Enrolment in both trial categories may continue until the required numbers in both groups have been reached.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Not yet recruiting
        • Aalborg University Hospital
        • Contact:
          • Rasmus Kjeldsen, MD
        • Contact:
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ditte S Moeller, As prof. MSc PhD
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lotte Nygaard, MD, PhD
        • Sub-Investigator:
          • Mirjana Josipovic, MSc, PhD
        • Sub-Investigator:
          • Ivan R Vogelius, Prof. MSc, PhD.
        • Sub-Investigator:
          • Isak H Wahlstedt, MSc
        • Sub-Investigator:
          • Morten Suppli, MD, PhD
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev University Hospital
        • Contact:
        • Contact:
          • Wiviann Ottosson, MSc
        • Sub-Investigator:
          • Svetlana Borissova, MD
        • Sub-Investigator:
          • Fatma Gaard-Petersen, MSC
        • Sub-Investigator:
          • Mette Felter, MD
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
        • Contact:
          • Tine Bj Nielsen, MSc, PhD
        • Sub-Investigator:
          • Olfred S Hansen, Prof. MD. PhD.
        • Sub-Investigator:
          • Lotte H Land, MD. PhD.
        • Sub-Investigator:
          • Morten Nielsen, MSc, PhD.
        • Sub-Investigator:
          • Anders Bertelsen, MSc, PhD.
      • Vejle, Denmark, 7100
        • Recruiting
        • Department of Oncology, Lillebaelt Hospital
        • Contact:
        • Contact:
          • Rune S Thing, MSc
        • Sub-Investigator:
          • Torben S Hansen, MD
        • Sub-Investigator:
          • Mikkel D Lund, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Tumor with intra-bronchial or intra-tracheal growth, as assessed on a diagnostic CT/MR-scan or endoscopic procedure
  • If the patient has received previous radiotherapy, the combined dose at the radiation site must be evaluated by the treating physician and preferably not exceed the dose constraints
  • Patient cannot tolerate the physical set up required for SBRT. • Uncontrolled intercurrent illness
  • Pregnancy
  • Patient participating in another interventional study
  • For patients in STAR-LUNG, lack of MR compatibility due to pacemaker, inserted steel or similar.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: STRICT LUNG
Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.
Other Names:
  • Stereotactic radiotherapy for centrally located lung tumors
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).
Procedure: STAR LUNG
Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Other Names:
  • Stereotactic radiotherapy for ultra-centrally located lung tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time Frame: Assessed at 6 months
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Assessed at 6 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time Frame: Assessed at 12 months
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Assessed at 12 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time Frame: Assessed at 2 years
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Assessed at 2 years
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time Frame: Assessed at 5 years
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Assessed at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local progression free survival (LPFS)
Time Frame: Up to 10 years
Local progression-free survival (LPFS) is defined from the start of radiotherapy treatment until death or date of local recurrence. Events are death and local recurrence.
Up to 10 years
Overall survival (OS)
Time Frame: Up to 10 years
Overall survival (OS) is defined as the time from start of radiotherapy treatment until death by any cause.
Up to 10 years
Disease free survival (DFS)
Time Frame: Up to 10 years
Disease free survival (DFS) is defined from start of radiotherapy treatment until date of first locoregional or metastatic recurrence or death from any cause. Events are recurrence and death.
Up to 10 years
Time-to-treatment failure (TTF)
Time Frame: Up to 10 years
Time-to-treatment failure (TTF) is defined as time from start of radiotherapy treatment until the date of relapse; the patient has withdrawn patient consent or premature termination of SBRT due to toxicity. Events are death due to primary cancer, death due to protocol treatment and date of local, regional or metastatic recurrence.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Aarhus University Hospital
University of Copenhagen
Vejle Hospital
Aalborg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

December 30, 2025

Study Completion (Anticipated)

May 1, 2033

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 24, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21041667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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