Non-small Cell Lung CancerNCT03624907
Daily vs. Non-Daily SBRT for NSCLC
A study testing Daily Stereotactic Body Radiotherapy and Non-Daily Stereotactic Body Radiotherapy in people with Non-small Cell Lung Cancer, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Daily Stereotactic Body Radiotherapy and Non-Daily Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2018to 16 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Radiation Oncology Davis Cancer Pavilion
Gainesville, Florida, 32611
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Daily Stereotactic Body Radiotherapy, Non-Daily Stereotactic Body Radiotherapy
- Keywords
- stereotactic body radiotherapy (SBRT)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Stereotactic Body RadiotherapyRadiation
After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.
Non-Daily Stereotactic Body RadiotherapyRadiation
After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive Daily Treatment | Other | 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 Receives: Radiation: Daily Stereotactic Body Radiotherapy |
| Non-Consecutive Daily Treatment | Other | 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 Receives: Radiation: Non-Daily Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years
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
Measured: Two years
Secondary outcomes (5)
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).
Measured: 2 years
Document patient-reported quality of life before, during, and after treatment
This will be done using quality of life surveys
Measured: 2 years
Evaluate circulating tumor DNA
This will be done by collecting blood prior to, during, and after treatment
Measured: 2 years
Overall Survival
Tracked through patient follow up
Measured: 2 years
Progression Free Survival
Tracked through patient follow up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start19 Oct 2018
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either daily or non-daily stereotactic body radiotherapy (SBRT).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- DiaCarta, Inc.
- Responsible party
- Sponsor
- Investigators
- Anamaria Yeung, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624907
- Sponsor's protocol ID
- IRB201801625
- Other IDs
- OCR17400
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03624907
- Acronym / sponsor ID
- IRB201801625
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- stereotactic body radiotherapy (SBRT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- DiaCarta, Inc.
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either daily or non-daily stereotactic body radiotherapy (SBRT).
| Arm | Type | Receives |
|---|---|---|
| Consecutive Daily Treatment | Other | Radiation: Daily Stereotactic Body RadiotherapyParticipant will receive daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 4-5 days |
| Non-Consecutive Daily Treatment | Other | Radiation: Non-Daily Stereotactic Body RadiotherapyParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Stereotactic Body RadiotherapyAfter randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion. | Radiation | Consecutive Daily Treatment |
| Non-Daily Stereotactic Body RadiotherapyAfter randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion. | Radiation | Non-Consecutive Daily Treatment |
Primary outcome
Two-year control measured by CT (computerized tomography) scan
Time frame: Two years
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
Time frame: Two years
Control defined as PET imaging with uptake of a similar intensity as the pretreatment staging PET
5 secondary outcomes
Document acute and late toxicity related to treatment
Time frame: 2 years
Document patient-reported quality of life before, during, and after treatment
Time frame: 2 years
Evaluate circulating tumor DNA
Time frame: 2 years
Overall Survival
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anamaria Yeung, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Stereotactic Body Radiotherapy and Non-Daily Stereotactic Body Radiotherapy in people with Non-small Cell Lung Cancer, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year control measured by CT (computerized tomography) scan (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.