Back to resultsProphylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD)
Primary Purpose
Spine Metastases
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prophylactic Radiotherapy
Standard of care systemic therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Spine Metastases focused on measuring Radiotherapy (RT), Palliative radiotherapy, High-risk asymptomatic spine metastases, Minimal asymptomatic spine metastases
Eligibility Criteria
Inclusion Criteria:
- Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
- Bulkiest sites of spinal osseous disease ≥ 2cm,
- Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
- Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
- Vertebral body compression deformity > 50%.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Age ≥ 18 years.
- Able to provide informed consent.
- Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
Exclusion Criteria:
- Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- Serious medical co-morbidities precluding RT.
- Pregnant or lactating women.
- Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- Leptomeningeal disease.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Sites / Locations
- Miami Cancer Institute at Baptist Health South FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Systemic Therapy or Surveillance
Prophylactic Radiation Therapy
Arm Description
Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy)
Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by: Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension) Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1) Disease with posterior element involvement (facet(s), interspinous) Compression Deformity > 50%
Outcomes
Primary Outcome Measures
Number of patients who have skeletal-related events (SREs)
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
Secondary Outcome Measures
Number of skeletal-related event (SRE) hospitalizations
Number of hospitalizations attributed to skeletal-related events (SREs)
Pain-related quality of life
Pain-related quality of life using the Brief Pain Inventory (BPI) form. The BPI is a 17-item patient self-rating scale assessing demographic data, use of medications, as well as the sensory and reactive components of pain. The scale is from 0-10, and there are breakpoints between scores of 4 and 5 and between 6 and 7, indicating that mild pain correlates with scores of 1-4, moderate pain with 5-6, and severe pain with scores of 7-10.
Health care utilities and quality of life
Health care utilities and quality of life using the EuroQol Group EQ-5D-5L form. It has been developed to generate a generic cardinal index of health, thus giving it considerable potential for future use in economic evaluation. The EQ-5D-5L is a two-part, patient-completed questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems. The second component is the visual analog scale, where the participant rates their own overall health on a scale of 0 (worst health) to 100 (best health).
Pain-free survival (PFS)
Pain-free survival (PFS) is defined as the time from study entry to until the start of opioid use or until death.
Overall survival (OS)
Overall survival (OS) is defined as the time from study entry until death.
Adverse event frequency and severity
Evaluate CTCAE v5 toxicity events in the upfront RT arm by tabulating all toxicities and summarizing the CTCAE v5 scores.
Full Information
NCT ID
NCT05534321
First Posted
September 6, 2022
Last Updated
September 25, 2023
Sponsor
Baptist Health South Florida
1. Study Identification
Unique Protocol Identification Number
NCT05534321
Brief Title
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
Acronym
PROMISSeD
Official Title
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Metastases
Keywords
Radiotherapy (RT), Palliative radiotherapy, High-risk asymptomatic spine metastases, Minimal asymptomatic spine metastases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Systemic Therapy or Surveillance
Arm Type
Active Comparator
Arm Description
Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy)
Arm Title
Prophylactic Radiation Therapy
Arm Type
Experimental
Arm Description
Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by:
Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension)
Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1)
Disease with posterior element involvement (facet(s), interspinous)
Compression Deformity > 50%
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Radiotherapy
Intervention Description
Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
Intervention Type
Drug
Intervention Name(s)
Standard of care systemic therapy
Intervention Description
Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
Primary Outcome Measure Information:
Title
Number of patients who have skeletal-related events (SREs)
Description
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of skeletal-related event (SRE) hospitalizations
Description
Number of hospitalizations attributed to skeletal-related events (SREs)
Time Frame
1 year
Title
Pain-related quality of life
Description
Pain-related quality of life using the Brief Pain Inventory (BPI) form. The BPI is a 17-item patient self-rating scale assessing demographic data, use of medications, as well as the sensory and reactive components of pain. The scale is from 0-10, and there are breakpoints between scores of 4 and 5 and between 6 and 7, indicating that mild pain correlates with scores of 1-4, moderate pain with 5-6, and severe pain with scores of 7-10.
Time Frame
3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Title
Health care utilities and quality of life
Description
Health care utilities and quality of life using the EuroQol Group EQ-5D-5L form. It has been developed to generate a generic cardinal index of health, thus giving it considerable potential for future use in economic evaluation. The EQ-5D-5L is a two-part, patient-completed questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems. The second component is the visual analog scale, where the participant rates their own overall health on a scale of 0 (worst health) to 100 (best health).
Time Frame
3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Title
Pain-free survival (PFS)
Description
Pain-free survival (PFS) is defined as the time from study entry to until the start of opioid use or until death.
Time Frame
Until 1 year
Title
Overall survival (OS)
Description
Overall survival (OS) is defined as the time from study entry until death.
Time Frame
Until 1 year
Title
Adverse event frequency and severity
Description
Evaluate CTCAE v5 toxicity events in the upfront RT arm by tabulating all toxicities and summarizing the CTCAE v5 scores.
Time Frame
3 months, 6 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
Bulkiest sites of spinal osseous disease ≥ 2cm,
Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
Vertebral body compression deformity > 50%.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Age ≥ 18 years.
Able to provide informed consent.
Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
Exclusion Criteria:
Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
Serious medical co-morbidities precluding RT.
Pregnant or lactating women.
Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
Leptomeningeal disease.
Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupesh R Kotecha, MD
Phone
17865962000
Email
rupeshk@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Maria C Avendano, MD
Phone
17865962000
Email
mariaave@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupesh R Kotecha, MD
Organizational Affiliation
Miami Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
Phone
786-527-7642
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
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