Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Spine Metastases Clinical Trial

— PROMISSeD  

Official title:

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534321
• Other study ID #: 2021-KOT-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 29, 2022
• Est. completion date: September 2027

Study information

• Verified date: December 2023
• Source: Baptist Health South Florida
• Contact: Rupesh R Kotecha, MD
• Phone: 17865962000
• Email: rupeshk[@]baptisthealth.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.

2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:

1. Bulkiest sites of spinal osseous disease = 2cm,

2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)

3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.

4. Vertebral body compression deformity > 50%.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

4. Age = 18 years.

5. Able to provide informed consent.

6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.

Exclusion Criteria:

1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.

2. Serious medical co-morbidities precluding RT.

3. Pregnant or lactating women.

4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.

5. Leptomeningeal disease.

6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Diseases
• Spine Metastases

Intervention

Radiation:
• Prophylactic Radiotherapy
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.

Drug:
• Standard of care systemic therapy
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.

Locations

Country	Name	City	State
United States	Miami Cancer Institute at Baptist Health South Florida	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Secondary	Number of skeletal-related event (SRE) hospitalizations	Number of hospitalizations attributed to skeletal-related events (SREs)	1 year
Secondary	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.	3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Secondary	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).	3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Secondary	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.	Until 1 year
Secondary	Overall survival (OS)	Overall survival (OS) is defined as the time from study entry until death.	Until 1 year
Secondary	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.	3 months, 6 months, and 12 months