Neoplasm MetastasisPhase 2NCT03029416
Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
A Phase 2 study testing Stereotactic Body Radiation Therapy in people with Neoplasm Metastasis and Cancer, run by Ronald McGarry at 1 site in United States.
Trial summary
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Cancer, Radiation Therapy Complication
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 9 Aug 2018
- Phase
- Phase 2
- 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
- Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
- Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- Age ≥18 years
- ECOG performance status >/= 2 (Karnofsky≥60%)).
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
- Patients who are receiving any other investigational agents.
- Patients with active systemic, pulmonary, or pericardial infection.
- Pregnant or lactating women
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Chemotherapy concurrent with SBRT is not allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.
Read the detailed description
Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.
- Conditions
- Neoplasm Metastasis, Cancer, Radiation Therapy Complication
- Being tested
- Stereotactic Body Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Stereotactic Body Radiation Therapy using different fractionation schedules
| Study group | Role | What they receive |
|---|---|---|
| Single Fraction of SBRT | Experimental | Stereotactic Body Radiation Therapy delivered in a single session on one day Receives: Radiation: Stereotactic Body Radiation Therapy |
| Fractionated SBRT | Experimental | Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Disease Control Rates
Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start26 Oct 2017
- Primary completion20 Jul 2018
- Study completion9 Aug 2018
Why it stopped: PRMC Administrative Disapproval - Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 Gy single fraction SBRT 18 Gy x three fractions
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald McGarry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald McGarry, University of Kentucky
- Investigators
- Ronald McGarry, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029416
- Sponsor's protocol ID
- MCC-16-MULTI-21
- Other IDs
- MCC-16-LUN-101
- Status last verified
- Oct 2018
- First submitted
- 20 Jan 2017
- Last updated
- 15 Oct 2018
- 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
- ClinicalTrials.gov ID
- NCT03029416
- Acronym / sponsor ID
- MCC-16-MULTI-21
- Conditions
- Neoplasm Metastasis, Cancer, Radiation Therapy Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PRMC Administrative Disapproval - Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ronald McGarryUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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.
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.
Detailed description
Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 Gy single fraction SBRT 18 Gy x three fractions
| Arm | Type | Receives |
|---|---|---|
| Single Fraction of SBRT | Experimental | Radiation: Stereotactic Body Radiation TherapyStereotactic Body Radiation Therapy delivered in a single session on one day |
| Fractionated SBRT | Experimental | Radiation: Stereotactic Body Radiation TherapyStereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
- Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- Age ≥18 years
- ECOG performance status >/= 2 (Karnofsky≥60%)).
Key exclusion criteria (7 listed)
- Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
- Patients who are receiving any other investigational agents.
- Patients with active systemic, pulmonary, or pericardial infection.
- Pregnant or lactating women
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
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 |
|---|---|---|
| Stereotactic Body Radiation TherapyStereotactic Body Radiation Therapy using different fractionation schedules | Radiation | Fractionated SBRT, Single Fraction of SBRT |
Primary outcome
Local Disease Control Rates
Time frame: 6 MONTHS
Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- 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.
Ronald McGarry, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy in people with Neoplasm Metastasis and Cancer, run by Ronald McGarry at 1 site 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Local Disease Control Rates (time frame: 6 MONTHS). 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 15 Oct 2018.