Clinical trial NCT04068649: Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Malignant Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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:

I. 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:

I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.

EXPLORATORY OBJECTIVES:

I. 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.

V. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  * 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

Primary outcomes:
measure: Pain responses
timeFrame: Baseline up to 12 weeks
measure: Change in Quality of life
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks
Other outcomes:
measure: Changes in immune markers
timeFrame: Up to 12 weeks
measure: Hospitalization resulting from radiation treatment
timeFrame: Up to 12 weeks
measure: Cognitive function
timeFrame: Up to 12 weeks
measure: Pain catastrophizing scale
timeFrame: Up to 12 weeks
measure: Impact of the time of day of treatment on patient outcomes
timeFrame: Up to 12 weeks
measure: Frailty Assessment
timeFrame: Up to 12 weeks
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Hills
country: United States
facility: The Cancer Institute at St. Francis Hospital
state: New York
city: West Islip
country: United States
facility: Good Samaritan Hospital
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: