Status:
SUSPENDED
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Radiation Therapy
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm receiving standar...
Detailed Description
Primary Objective To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm...
Eligibility Criteria
Inclusion
- The inclusion criteria for this study are as follows:
- Age ≥ 18 years
- Zubrod performance status 0-2
- Pathology-proven cancer, with primary site outside of the central nervous system
- Clinical (based on physical exam or imaging) or pathological diagnosis of metastatic disease, for which curative intent treatment is not feasible and treatment goals are palliative. Both patients with newly diagnosed metastatic disease, and those who have a metastatic relapse after prior curative-intent treatment for their malignancy, are eligible.
- Estimated life expectancy 6-24 months. Guidelines for estimating life expectancy will be based on best available evidence, based primarily on tumor type, systemic therapy used and its expected outcome, line of systemic therapy, and in some cases patients' initial response to systemic therapy, along with the enrolling medical oncologist's judgement.
- Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)
- Ability to understand and the willingness to sign a written informed consent document
- If a patient is actively participating in another clinical trial utilizing an investigation agent, they are still eligible for participation in this study unless radiation therapy is explicitly not allowed in that trial.
Exclusion
- The exclusion criteria for this study are as follows:
- Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):
- Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible)
- Breast cancer responsive to hormonal therapy
- Endometrial cancer responsive to hormonal therapy
- Patients receiving first line systemic therapy, for whom median progression-free survival is greater than 6 months, and response to therapy has not been assessed yet.
- Patients considered metastatic only due to pleural or peritoneal metastases without metastases to any other organ are excluded since palliative radiation therapy is less commonly used in these cases.
- Patients with cancer considered incurable that is locally advanced but nonmetastatic.
- Patients with leukemia or primary central nervous system cancers will be excluded since these patients less commonly are treated with palliative radiation therapy. Patients with lymphoma and multiple myeloma are eligible if they meet the other eligibility criteria.
- Any patient for whom standard-of-care radiation oncology referral would be immediately indicated for palliative radiation therapy. The purpose of this is to ensure that patients in the control arm will not have a detriment in their care by not seeing a radiation oncologist at enrollment,
- In order to avoid bias from prior standard-of-care radiation oncology involvement, patients will also be excluded if they are undergoing active follow-up with a radiation oncologist after prior palliative radiation therapy.
- History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, adrenal insufficiency, chronic liver disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects.
- Cognitively impaired adults lacking decision-making capacity or unable to consent. -
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05351294
Start Date
July 13 2023
End Date
December 30 2027
Last Update
January 7 2026
Active Locations (6)
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1
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
2
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
3
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
4
Malcolm David Mattes, MD
Newark, New Jersey, United States, 07103