Can early radiation oncology visits boost quality of life for advanced cancer patients?
NCT ID NCT05351294
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether having a radiation oncologist involved early in care, alongside standard treatment, can improve quality of life for people with metastatic cancer. About 156 adults with cancer that has spread and is not curable will be randomly assigned to either standard care alone or standard care plus early radiation oncology visits. The main goal is to see if quality of life scores are higher at six months in the group with early radiation involvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- early radiation oncology consultation
- What this could lead to
- If successful, this could show that involving a radiation oncologist early in care improves quality of life for people with metastatic cancer.
- What could go wrong
- This trial is currently suspended, so results may be delayed or never completed. The benefit is measured by questionnaires, which may not capture meaningful changes for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Malcolm David Mattes, MD
Newark, New Jersey, 07103, United States
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RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873, United States
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RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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