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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)

Primary Purpose

Lung Cancer, Metastases to Lung, Radiotherapy Side Effect

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

STRICT LUNG

STAR LUNG

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Stereotactic body radiotherapy (SBRT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aalborg University Hospital
Aarhus University HospitalRecruiting
RigshospitaletRecruiting
Herlev University HospitalRecruiting
Odense University HospitalRecruiting
Department of Oncology, Lillebaelt HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

STRICT LUNG

STAR LUNG

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Secondary Outcome Measures

Local progression free survival (LPFS)

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.

Overall survival (OS)

Overall survival (OS) is defined as the time from start of radiotherapy treatment until death by any cause.

Disease free survival (DFS)

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.

Time-to-treatment failure (TTF)

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.

Full Information

NCT ID

NCT05354596

First Posted

April 18, 2022

Last Updated

March 1, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05354596

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).

Acronym

STRICTSTARLUNG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

December 30, 2025 (Anticipated)

Study Completion Date

May 1, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Metastases to Lung, Radiotherapy Side Effect

Keywords

Stereotactic body radiotherapy (SBRT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Radiation: SBRT of central located and ultra-centrally located tumors in the lung. Primary lung tumors and lung metastasis from solid tumors.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

STRICT LUNG

Arm Type

Experimental

Arm Description

Arm Title

STAR LUNG

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

STRICT LUNG

Other Intervention Name(s)

Stereotactic radiotherapy for centrally located lung tumors

Intervention Description

Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.

Intervention Type

Procedure

Intervention Name(s)

STAR LUNG

Other Intervention Name(s)

Stereotactic radiotherapy for ultra-centrally located lung tumors

Intervention Description

Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.

Primary Outcome Measure Information:

Title

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Description

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Time Frame

Assessed at 6 months

Title

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Description

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Time Frame

Assessed at 12 months

Title

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Description

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Time Frame

Assessed at 2 years

Title

Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)

Description

Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.

Time Frame

Assessed at 5 years

Secondary Outcome Measure Information:

Title

Local progression free survival (LPFS)

Description

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.

Time Frame

Up to 10 years

Title

Overall survival (OS)

Description

Overall survival (OS) is defined as the time from start of radiotherapy treatment until death by any cause.

Time Frame

Up to 10 years

Title

Disease free survival (DFS)

Description

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.

Time Frame

Up to 10 years

Title

Time-to-treatment failure (TTF)

Description

Time Frame

Up to 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mette Pøhl, MD, PhD

Phone

+4535451824

mette.poehl@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Lone Hoffmann, Ass. Prof, MSc, PhD

Phone

+4529939779

lone.hoffmann@aarhus.rm.dk

Facility Information:

Facility Name

Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rasmus Kjeldsen, MD

First Name & Middle Initial & Last Name & Degree

Hella Sand, MSc

hmbs@rn.dk

Facility Name

Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Azza A Khalil, MD, PhD

azza.khalil@auh.rm.dk

First Name & Middle Initial & Last Name & Degree

Marianne M Knap, MD, PhD

mari.knap@auh.rm.dk

First Name & Middle Initial & Last Name & Degree

Ditte S Moeller, As prof. MSc PhD

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mette pøhl, MD, PhD

Phone

41667681

mette.poehl@regionh.dk

First Name & Middle Initial & Last Name & Degree

Cécile Peucelle, MSc, PhD

cecile.anne.peucelle@regionh.dk

First Name & Middle Initial & Last Name & Degree

Lotte Nygaard, MD, PhD

First Name & Middle Initial & Last Name & Degree

Mirjana Josipovic, MSc, PhD

First Name & Middle Initial & Last Name & Degree

Ivan R Vogelius, Prof. MSc, PhD.

First Name & Middle Initial & Last Name & Degree

Isak H Wahlstedt, MSc

First Name & Middle Initial & Last Name & Degree

Morten Suppli, MD, PhD

Facility Name

Herlev University Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gitte F Persson, MD, PhD

Gitte.Persson@regionh.dk

First Name & Middle Initial & Last Name & Degree

Wiviann Ottosson, MSc

First Name & Middle Initial & Last Name & Degree

Svetlana Borissova, MD

First Name & Middle Initial & Last Name & Degree

Fatma Gaard-Petersen, MSC

First Name & Middle Initial & Last Name & Degree

Mette Felter, MD

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tine Schytte, Prof. MD. PhD

Tine.Schytte@rsyd.dk

First Name & Middle Initial & Last Name & Degree

Tine Bj Nielsen, MSc, PhD

First Name & Middle Initial & Last Name & Degree

Olfred S Hansen, Prof. MD. PhD.

First Name & Middle Initial & Last Name & Degree

Lotte H Land, MD. PhD.

First Name & Middle Initial & Last Name & Degree

Morten Nielsen, MSc, PhD.

First Name & Middle Initial & Last Name & Degree

Anders Bertelsen, MSc, PhD.

Facility Name

Department of Oncology, Lillebaelt Hospital

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlotte Kristiansen, MD

Charlotte.Kristiansen@rsyd.dk

First Name & Middle Initial & Last Name & Degree

Rune S Thing, MSc

First Name & Middle Initial & Last Name & Degree

Torben S Hansen, MD

First Name & Middle Initial & Last Name & Degree

Mikkel D Lund, MSc

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35421513

Citation

Hoffmann L, Persson GF, Nygard L, Nielsen TB, Borrisova S, Gaard-Petersen F, Josipovic M, Khalil AA, Kjeldsen R, Knap MM, Kristiansen C, Moller DS, Ottosson W, Sand H, Thing R, Pohl M, Schytte T. 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. Radiother Oncol. 2022 Jun;171:53-61. doi: 10.1016/j.radonc.2022.04.005. Epub 2022 Apr 11.

Results Reference

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Learn more about this trial

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).

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