Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Manag… (NCT05351294) | Clinical Trial Compass
SuspendedPhase 3
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet
Stopped: Interim analysis
United States156 participantsStarted 2023-07-13
Plain-language 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 standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure of Health-related quality of life (HRQL) at six months
Timeframe: At Six Months
Trial details
NCT IDNCT05351294
SponsorRutgers, The State University of New Jersey
. 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 criteria
. 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.