Metastatic Malignant NeoplasmPhase 2NCT04068649
Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
A Phase 2 study testing Palliative Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Malignant Neoplasm, run by Roswell Park Cancer Institute at 3 sites in United States.
Trial summary
This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm
- What is being tested?
- Palliative Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Nov 2019to 18 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Pathologically confirmed malignancy
- Clinical or pathologic evidence of metastatic disease
- A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted
- Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease)
- Participants with known brain metastases
- Pregnant or nursing female participants
- Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
- Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
- Severe, active co-morbidity defined as follows:
Show all 16Show fewer
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
- Transmural myocardial infarction within the last 3 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Unwilling or unable to follow protocol requirements
- Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Anurag K. Singh, 716-845-3218, Anurag.Singh@roswellpark.org
Anurag K. Singh
- Recruiting
The Cancer Institute at St. Francis Hospital
East Hills, New York, 11548
Anne Vinokur, MD, 516-222-2020, anne.vinokur@chsli.org
- Recruiting
Good Samaritan Hospital
West Islip, New York, 11795
Johnny Kao, MD, 631-376-4047, Johnny.kao@chsli.org
About this study
Official title: A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease.
SECONDARY OBJECTIVES:
- Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.
EXPLORATORY OBJECTIVES:
- Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer.
IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes.
- Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician.
ARM II: Patients undergo single fraction SBRT.
After completion of study treatment, patients may be followed up at 5 and 12 weeks.
- Conditions
- Metastatic Malignant Neoplasm
- Being tested
- Palliative Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Radiation TherapyRadiation
Undergo palliative RT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (palliative RT) | Experimental | Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician. Receives: Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (SBRT) | Experimental | Patients undergo single fraction SBRT. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain responses
Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.
Measured: Baseline up to 12 weeks
Change in Quality of life
Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.
Measured: Baseline up to 12 weeks
Secondary outcomes (1)
Overall survival
Will be assessed by chart review. Will be carried out using a Cox proportional hazards regression model.
Measured: Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Nov 2019
- Primary completion18 Nov 2027 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag K Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068649
- Sponsor's protocol ID
- I 81318
- Other IDs
- NCI-2019-04859, I 81318
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
- ClinicalTrials.gov ID
- NCT04068649
- Acronym / sponsor ID
- I 81318
- Conditions
- Metastatic Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Nov 2027 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 28 Aug 2019 (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.
This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease.
SECONDARY OBJECTIVES:
- Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.
EXPLORATORY OBJECTIVES:
- Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer.
IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes.
- Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician.
ARM II: Patients undergo single fraction SBRT.
After completion of study treatment, patients may be followed up at 5 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (palliative RT) | Experimental | Radiation: Palliative Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician. |
| Arm II (SBRT) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients undergo single fraction SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed malignancy
- Clinical or pathologic evidence of metastatic disease
- A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted
Key exclusion criteria (16 listed)
- Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease)
- Participants with known brain metastases
- Pregnant or nursing female participants
- Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
- Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
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 |
|---|---|---|
| Palliative Radiation TherapyUndergo palliative RT | Radiation | Arm I (palliative RT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (palliative RT), Arm II (SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (palliative RT), Arm II (SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Arm II (SBRT) |
Primary outcome
Pain responses
Time frame: Baseline up to 12 weeks
Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.
Change in Quality of life
Time frame: Baseline up to 12 weeks
Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.
1 secondary outcome
Overall survival
Time frame: Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
The Cancer Institute at St. Francis Hospital
East Hills, United States
Anurag K Singh principal investigator
Roswell Park Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palliative Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Malignant Neoplasm, run by Roswell Park Cancer Institute at 3 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain responses (time frame: Baseline up to 12 weeks). 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 30 Apr 2026.