Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD)

Baptist Health South Florida

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Spine Metastases

Treatments: Radiation: Prophylactic Radiotherapy; Drug: Standard of care systemic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05534321

2021-KOT-002

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Standard of Care Systemic Therapy or Surveillance

Active Comparator group

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)

Treatment:

Drug: Standard of care systemic therapy

Prophylactic Radiation Therapy

Experimental group

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: 1. Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension) 2. Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1) 3. Disease with posterior element involvement (facet(s), interspinous) 4. Compression Deformity \> 50%

Treatment:

Radiation: Prophylactic Radiotherapy