Early radiation oncology involvement with standard cancer care

Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies

This study is testing if adding early radiation treatment to regular cancer care can help improve the quality of life for people with metastatic cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 6 sites (Jersey City, New Jersey and 5 other locations)
• Trial ID: NCT05351294 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess whether early involvement of radiation oncology, in conjunction with standard oncologic care, can enhance health-related quality of life (HRQL) for patients with metastatic cancer. The primary objective is to compare HRQL scores at six months between patients receiving the combined approach and those receiving standard care alone, using the EORTC QLQ-C30 questionnaire. Secondary objectives include evaluating improvements in specific HRQL domains and the impact on severe cancer-induced symptoms, as measured by emergency visits and hospitalizations. The study will also conduct a cost-utility analysis if significant differences are observed in the primary endpoint.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathology-proven metastatic cancer and a life expectancy of 6-24 months.

Not a fit: Patients with central nervous system tumors or those not seeking palliative treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing palliative care for metastatic cancer.

How similar studies have performed: Other studies have shown promising results with early radiation oncology involvement in palliative care, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

The inclusion criteria for this study are as follows:

1. Age ≥ 18 years
2. Zubrod performance status 0-2
3. Pathology-proven cancer, with primary site outside of the central nervous system
4. 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.
5. 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.
6. Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)
7. Ability to understand and the willingness to sign a written informed consent document
8. 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 Criteria:

The exclusion criteria for this study are as follows:

1. Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):

   1. Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible)
   2. Breast cancer responsive to hormonal therapy
   3. Endometrial cancer responsive to hormonal therapy
   4. 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.
2. 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.
3. Patients with cancer considered incurable that is locally advanced but nonmetastatic.
4. 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.
5. 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,
6. 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.
7. History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible)
8. 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.
9. Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects.
10. Cognitively impaired adults lacking decision-making capacity or unable to consent. -

Where this trial is running

Jersey City, New Jersey and 5 other locations

• RWJBarnabas Health Jersey City Medical Center — Jersey City, New Jersey, United States (Recruiting)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Recruiting)
• Malcolm David Mattes, MD — Newark, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — Somerset, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Malcolm Mattes, MD — Rutgers Cancer Institute of New Jersey
• Study coordinator: Malcolm Mattes, MD

Conditions Radiation Therapy; Metastatic Cancer; Quality of Life; Palliative Care and Supportive Care