Back to resultsDaily vs. Non-Daily SBRT for NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Stereotactic Body Radiotherapy
Non-Daily Stereotactic Body Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring stereotactic body radiotherapy (SBRT)
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age (no upper age limit).
- A diagnosis of non-small cell lung cancer, T1-2 N0 M0 either with histologic confirmation or with documented interval growth of the index lesion on two interval computed tomography (CT) chest scans and an SUVmax of the lesion ≥ 3.0 on a pretreatment PET scan.
- Patient must be deemed medically inoperable or refuse surgery.
- Radiographic evaluation of the mediastinum and distant sites with a CT scan of the chest and PET scan.
- For T2b N0 patients, radiographic evaluation of the brain with magnetic resonance imaging (MRI) of the brain unless the patient has contraindications to an MRI scan (in which case a CT scan of the head is necessary).
- For central T1 N0 and all T2 N0 patients, pathologic sampling (either via endobronchial ultrasound-guided biopsy [EBUS] or mediastinoscopy) of mediastinal lymph nodes is required.
- ECOG Performance Status 0-2.
- For women of childbearing potential, negative pregnancy test within 2 weeks prior to SBRT treatment.
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide specific informed consent prior to study entry.
- Women of childbearing potential and male participants who are sexually active must use adequate contraception during treatment and for 6 weeks following treatment.
Exclusion Criteria:
- Prior history of radiation therapy to the thorax that would likely increase the risk of serious complications from the radiotherapy delivered on this protocol.
- Prior history of lung cancer.
- Currently taking disease-modifying rheumatoid drugs (DMRDs).
- Severe, active co-morbidity, defined as follows:
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that coagulation parameters are not required for entry into this protocol.
- Prior organ transplant.
- Systemic lupus.
- Psoriatic arthritis.
- Known to be HIV positive. HIV-positive patients are known to have worse clinical outcomes, especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.
Sites / Locations
- Department of Radiation Oncology Davis Cancer Pavilion
- University of Florida Health Proton Therapy Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Consecutive Daily Treatment
Non-Consecutive Daily Treatment
Arm Description
Participant will receive daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 4-5 days
Participant will receive non-daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 8-12 days
Outcomes
Primary Outcome Measures
Two-year control measured by CT (computerized tomography) scan
Control defined as Less than 20% increase in the largest dimension of treated tumor measurable by CT
Two year control measured by PET (positron emission tomography) scan
Control defined as PET imaging with uptake of a similar intensity as the pretreatment staging PET
Secondary Outcome Measures
Document acute and late toxicity related to treatment
This will be assessed using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
Document patient-reported quality of life before, during, and after treatment
This will be done using quality of life surveys
Evaluate circulating tumor DNA
This will be done by collecting blood prior to, during, and after treatment
Overall Survival
Tracked through patient follow up
Progression Free Survival
Tracked through patient follow up
Full Information
NCT ID
NCT03624907
First Posted
August 6, 2018
Last Updated
September 27, 2021
Sponsor
University of Florida
Collaborators
DiaCarta, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03624907
Brief Title
Daily vs. Non-Daily SBRT for NSCLC
Official Title
Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
DiaCarta, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if stereotactic body radiotherapy (SBRT) on non-consecutive days will increase the chances of curing non-small cell lung cancer when compared to daily treatment.
Detailed Description
The purpose of this study is to determine if treatment with stereotactic body radiotherapy (SBRT) on non-consecutive days will improve the chance of curing non-small cell lung cancer compared to treatment with SBRT on consecutive days. In either case, the dose of radiation is the same. Non-consecutive treatments will be at least 40 hours apart and no more than 100 hours apart. The total course of treatment will be 8-12 days. Consecutive treatments will be daily over 4-5 days within one calendar week. The total course of treatment will be 4-5 days.
The study team will assess if DNA from the tumor can be found in the blood to determine which patients respond quickest to radiotherapy. These results will not be made available to participants and will not change treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
stereotactic body radiotherapy (SBRT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either daily or non-daily stereotactic body radiotherapy (SBRT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consecutive Daily Treatment
Arm Type
Other
Arm Description
Participant will receive daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 4-5 days
Arm Title
Non-Consecutive Daily Treatment
Arm Type
Other
Arm Description
Participant will receive non-daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 8-12 days
Intervention Type
Radiation
Intervention Name(s)
Daily Stereotactic Body Radiotherapy
Intervention Description
After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.
Intervention Type
Radiation
Intervention Name(s)
Non-Daily Stereotactic Body Radiotherapy
Intervention Description
After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.
Primary Outcome Measure Information:
Title
Two-year control measured by CT (computerized tomography) scan
Description
Control defined as Less than 20% increase in the largest dimension of treated tumor measurable by CT
Time Frame
Two years
Title
Two year control measured by PET (positron emission tomography) scan
Description
Control defined as PET imaging with uptake of a similar intensity as the pretreatment staging PET
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Document acute and late toxicity related to treatment
Description
This will be assessed using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame
2 years
Title
Document patient-reported quality of life before, during, and after treatment
Description
This will be done using quality of life surveys
Time Frame
2 years
Title
Evaluate circulating tumor DNA
Description
This will be done by collecting blood prior to, during, and after treatment
Time Frame
2 years
Title
Overall Survival
Description
Tracked through patient follow up
Time Frame
2 years
Title
Progression Free Survival
Description
Tracked through patient follow up
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age (no upper age limit).
A diagnosis of non-small cell lung cancer, T1-2 N0 M0 either with histologic confirmation or with documented interval growth of the index lesion on two interval computed tomography (CT) chest scans and an SUVmax of the lesion ≥ 3.0 on a pretreatment PET scan.
Patient must be deemed medically inoperable or refuse surgery.
Radiographic evaluation of the mediastinum and distant sites with a CT scan of the chest and PET scan.
For T2b N0 patients, radiographic evaluation of the brain with magnetic resonance imaging (MRI) of the brain unless the patient has contraindications to an MRI scan (in which case a CT scan of the head is necessary).
For central T1 N0 and all T2 N0 patients, pathologic sampling (either via endobronchial ultrasound-guided biopsy [EBUS] or mediastinoscopy) of mediastinal lymph nodes is required.
ECOG Performance Status 0-2.
For women of childbearing potential, negative pregnancy test within 2 weeks prior to SBRT treatment.
Patients must be deemed able to comply with the treatment plan and follow-up schedule.
Patients must provide specific informed consent prior to study entry.
Women of childbearing potential and male participants who are sexually active must use adequate contraception during treatment and for 6 weeks following treatment.
Exclusion Criteria:
Prior history of radiation therapy to the thorax that would likely increase the risk of serious complications from the radiotherapy delivered on this protocol.
Prior history of lung cancer.
Currently taking disease-modifying rheumatoid drugs (DMRDs).
Severe, active co-morbidity, defined as follows:
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that coagulation parameters are not required for entry into this protocol.
Prior organ transplant.
Systemic lupus.
Psoriatic arthritis.
Known to be HIV positive. HIV-positive patients are known to have worse clinical outcomes, especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anamaria Yeung, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology Davis Cancer Pavilion
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Florida Health Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Daily vs. Non-Daily SBRT for NSCLC
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