Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05354596
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2022-04-18
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
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung STRICT-LUNG STAR-LUNG STUDY
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRICTSTARLUNG
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 05 -25 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 05 cm from the spinal cord heart and aorta
Ultra-centrally located tumors are tumors located within the 00 to 05 cm zone of trachea main bronchi or intermediate bronchus The patient will be excluded if the tumor invades the trachea bronchi esophagus or pericardiumheart 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
The tumor is considered central when the tumor is located within 05 -25 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 05 cm from the spinal cord heart and aorta
Ultra-centrally located tumors are tumors located within the 00 to 05 cm zone of trachea main bronchi or intermediate bronchus The patient will be excluded if the tumor invades the trachea bronchi esophagus or pericardiumheart 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None