Study of LUNG Stereotactic Adaptive Ablative Radiotherapy

Lung Cancer Clinical Trial

— LUNG STAAR  

Official title:

Phase II Study of LUNG Stereotactic Adaptive Ablative Radiotherapy for Central and Ultracentral Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04917224
• Other study ID #: 2020-KOT-005
• Status: Withdrawn
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: October 1, 2032

Study information

• Verified date: September 2023
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2032
• Est. primary completion date: October 1, 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years of age
• Clinical diagnosis of NSCLC
• Stage T1-2b (= 5 cm)

Exclusion Criteria:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted;
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Prior chemotherapy for the study cancer
• Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression
• Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lung Tumor

Intervention

Radiation:
• Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)
Cohort A will include 30 patients with central tumors; the dose regimen prescribed is 50 Gy (Gray) in 5 fractions with a 40 hour inter-fraction interval.
• Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)
Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion	Number of patients who completed treatment within +/- 5 days of intended treatment.	Plus or minus 5 days of treatment
Primary	Number of patients experiencing adverse events	No greater than 15 percent of patients experience a 12-month = grade 3 toxicity and =1 grade 5 toxicity possibly, probably, or definitely related to treatment.	12-month of treatment
Secondary	Primary Tumor Control Rate	Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.	1 year of treatment
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the first occurrence of local and/or regional disease progression, distant metastases, second primary tumor, or death due to any cause. PFS time is measured from the date of start of SBRT to the date of the failure event for PFS.	1 year of treatment
Secondary	Overall survival (OS)	Overall survival (OS) time is measured from the date of start of SBRT to the date of death due to any cause.	1 year of treatment
Secondary	Functional Assessment of Cancer Therapy - Lung (FACT-L)	The Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument has been extensively used for measuring quality of life in patients with lung cancer. There are 5 sections dealing with physical, family, emotional, functional well-being, and additional concerns. There are nine questions that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI (Trial Outcome Index) is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale.	Baseline
Secondary	EQ-5D-5L	The five-item index score from EQ-5D-5L will be used to generate utility scores that will lie between 0 (Worst health state) and 1 (Best health state).	3 and 12-month follow-up
Secondary	Late-Toxicity	Rate of late (>1 year) = grade 3 adverse events related to treatment	1 year of treatment

External Links

•   Related Info