Radiation TherapyPhase 3NCT05351294
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet
A Phase 3 study testing Questionnaires and Early Radiation Oncology Involvement Alongside Standard Oncologic Care in people with Radiation Therapy and Metastatic Cancer, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy, Metastatic Cancer
- What is being tested?
- Questionnaires and Early Radiation Oncology Involvement Alongside Standard Oncologic Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jul 2023to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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. -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Malcolm David Mattes, MD
Newark, New Jersey, 07103
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873
About this study
Official title: Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies
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.
Read the 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 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. Secondary Objectives
- To determine if early radiation oncology involvement improves other more detailed metrics of HRQL. This will be assessed using each of the 5 domains of the EORTC QLQ-C30 (physical, role, cognitive, emotional, social), each of the 5 dimensions of the EuroQol (EQ) 5D-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and the health index score and EQ visual analogue scale. If there are significant differences in the primary endpoint, then a cost-utility analysis will be conducted using a Markov model and the EQ-5D-5L index scores.
- To determine if early radiation oncology involvement will reduce the incidence of severe exacerbations/crises in cancer-induced symptoms (excluding systemic therapy-induced side effects), according to the number of emergency department visits and hospitalizations (total number of occurrences, and days admitted). These findings will be reported in the context of the number of palliative radiation therapy (PRT) courses and other invasive procedures that patients undergo, toxicities from those treatments, duration of time to initiation of tumor-directed treatment for exacerbation in symptoms, number of different lines of systemic therapy administered, and overall survival of each patient.
- To determine if early radiation oncology involvement improves other metrics of quality palliative care across the disease trajectory, as assessed by rates of early Palliative and Supportive Care (PSC) referral alongside standard oncologic care, documented advance care planning (based on the percentage of patients in both arms who complete a living will, and designate a power of attorney and resuscitation preferences in the medical record), hospice referral prior to death, and aggressiveness of care within 14 days of death (defined as meetings any of the following three criteria: chemotherapy, radiation, or surgery within 14 days before death, no hospice care, or admission to hospice 3 days or fewer before death).
- To assess patient/caregiver perceptions of prognosis, goals of treatment, and quality of communication with oncologists through the use of the Prognosis and Treatment Perceptions Questionnaire (PTPQ) in each arm
- To assess satisfaction with information-giving, availability of care, psychological care, and physical care in patients with advanced cancer using the FAMCAREP16 questionnaire in each arm
- To assess caregiver burden using the Montgomery-Borgatta Caregiver Burden Scale.
- Conditions
- Radiation Therapy, Metastatic Cancer
- Being tested
- Questionnaires, Early Radiation Oncology Involvement Alongside Standard Oncologic Care
- Keywords
- Quality of Life, Palliative Care and Supportive Care
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
All patients in Arm 2 will be seen and treated by one of three ROs with an interest in participating in this study, who will be trained by the PI to perform these visits reproducibly and with rigor. These will all be "regular" ROs, who like most ROs administer a mix of curative and PRT in their clinical practice; like most cancer centers, there are no ROs who formally subspecialize in PRT at our institution. Notably, patients in Arm 1 (control arm) will always have standard-of-care RO referral available for consideration of PRT if needed for symptom relief. However, patients in Arm 1 will be seen by other ROs without any specific training for this study. Any courses of PRT administered in either arm are at the discretion of the treating RO in terms of the timing, dose, fractionation, and treatment technique.
Early Radiation Oncology Involvement Alongside Standard Oncologic CareCombination product
Early Radiation Oncology Involvement Alongside Standard Oncologic Care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | All enrolled patients will receive standard oncologic care at the discretion of the treating physicians, but will also complete the EORTC QLQ-C30, EQ-5D-5L, PTPQ, FAMCARE-P16 at baseline before randomization. Follow-up assessment using EORTC QLQ-C30, PTPQ, FAMCARE-P16 will occur every 3 months, and using EQ-5D-5L will occur every 1 month, for a total of 12 months. These will be administered during standard-of-care clinic or infusion center visits. Receives: Other: Questionnaires |
| Arm 2 | Experimental | Patients enrolled in Arm 2 will also be seen be a radiation oncologist during the course of the study. The RO will review the patient's most recently completed EQ 5D-5L questionnaires and perform a complete History and Physical evaluation to determine if there is any immediate role for PRT. Based on the patient's type of cancer and areas of spread, the RO will also discuss types of symptoms that could develop in the future, and give instructions and educational materials to the patient so he/she can better identify those symptoms early on. Receives: Combination Product: Early Radiation Oncology Involvement Alongside Standard Oncologic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Health-related quality of life (HRQL) at six months
To see if early radiation oncology involvement alongside standard oncologic care will result in higher Health-related quality of life (HRQL) at six 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.
Measured: At Six Months
Secondary outcomes (2)
Levels of HRQL
To measure health-related quality of life (HRQL), by seeing if early radiation oncology involvement improves other more detailed metrics of HRQL.
Measured: 12 Months
Health Index Score
To measure the degree of severity or damage incurred by an organ or tissue.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start13 Jul 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malcolm David Mattes, MD, Rutgers, The State University of New Jersey
- Investigators
- Malcolm Mattes, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351294
- Sponsor's protocol ID
- 002168
- Other IDs
- Pro2021002435
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies
- ClinicalTrials.gov ID
- NCT05351294
- Acronym / sponsor ID
- 002168
- Conditions
- Radiation Therapy, Metastatic Cancer
- Keywords
- Quality of Life, Palliative Care and Supportive Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interim analysis
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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. Secondary Objectives
- To determine if early radiation oncology involvement improves other more detailed metrics of HRQL. This will be assessed using each of the 5 domains of the EORTC QLQ-C30 (physical, role, cognitive, emotional, social), each of the 5 dimensions of the EuroQol (EQ) 5D-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and the health index score and EQ visual analogue scale. If there are significant differences in the primary endpoint, then a cost-utility analysis will be conducted using a Markov model and the EQ-5D-5L index scores.
- To determine if early radiation oncology involvement will reduce the incidence of severe exacerbations/crises in cancer-induced symptoms (excluding systemic therapy-induced side effects), according to the number of emergency department visits and hospitalizations (total number of occurrences, and days admitted). These findings will be reported in the context of the number of palliative radiation therapy (PRT) courses and other invasive procedures that patients undergo, toxicities from those treatments, duration of time to initiation of tumor-directed treatment for exacerbation in symptoms, number of different lines of systemic therapy administered, and overall survival of each patient.
- To determine if early radiation oncology involvement improves other metrics of quality palliative care across the disease trajectory, as assessed by rates of early Palliative and Supportive Care (PSC) referral alongside standard oncologic care, documented advance care planning (based on the percentage of patients in both arms who complete a living will, and designate a power of attorney and resuscitation preferences in the medical record), hospice referral prior to death, and aggressiveness of care within 14 days of death (defined as meetings any of the following three criteria: chemotherapy, radiation, or surgery within 14 days before death, no hospice care, or admission to hospice 3 days or fewer before death).
- To assess patient/caregiver perceptions of prognosis, goals of treatment, and quality of communication with oncologists through the use of the Prognosis and Treatment Perceptions Questionnaire (PTPQ) in each arm
- To assess satisfaction with information-giving, availability of care, psychological care, and physical care in patients with advanced cancer using the FAMCAREP16 questionnaire in each arm
- To assess caregiver burden using the Montgomery-Borgatta Caregiver Burden Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: QuestionnairesAll enrolled patients will receive standard oncologic care at the discretion of the treating physicians, but will also complete the EORTC QLQ-C30, EQ-5D-5L, PTPQ, FAMCARE-P16 at baseline before randomization. Follow-up assessment using EORTC QLQ-C30, PTPQ, FAMCARE-P16 will occur every 3 months, and using EQ-5D-5L will occur every 1 month, for a total of 12 months. These will be administered during standard-of-care clinic or infusion center visits. |
| Arm 2 | Experimental | Combination Product: Early Radiation Oncology Involvement Alongside Standard Oncologic CarePatients enrolled in Arm 2 will also be seen be a radiation oncologist during the course of the study. The RO will review the patient's most recently completed EQ 5D-5L questionnaires and perform a complete History and Physical evaluation to determine if there is any immediate role for PRT. Based on the patient's type of cancer and areas of spread, the RO will also discuss types of symptoms that could develop in the future, and give instructions and educational materials to the patient so he/she can better identify those symptoms early on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAll patients in Arm 2 will be seen and treated by one of three ROs with an interest in participating in this study, who will be trained by the PI to perform these visits reproducibly and with rigor. These will all be "regular" ROs, who like most ROs administer a mix of curative and PRT in their clinical practice; like most cancer centers, there are no ROs who formally subspecialize in PRT at our institution. Notably, patients in Arm 1 (control arm) will always have standard-of-care RO referral available for consideration of PRT if needed for symptom relief. However, patients in Arm 1 will be seen by other ROs without any specific training for this study. Any courses of PRT administered in either arm are at the discretion of the treating RO in terms of the timing, dose, fractionation, and treatment technique. | Other | Arm 1 |
| Early Radiation Oncology Involvement Alongside Standard Oncologic CareEarly Radiation Oncology Involvement Alongside Standard Oncologic Care | Combination product | Arm 2 |
Primary outcome
Measure of Health-related quality of life (HRQL) at six months
Time frame: At Six Months
To see if early radiation oncology involvement alongside standard oncologic care will result in higher Health-related quality of life (HRQL) at six 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.
2 secondary outcomes
Levels of HRQL
Time frame: 12 Months
Health Index Score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Mattes, MD principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Questionnaires and Early Radiation Oncology Involvement Alongside Standard Oncologic Care in people with Radiation Therapy and Metastatic Cancer, run by Rutgers, The State University of New Jersey at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Health-related quality of life (HRQL) at six months (time frame: At Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.