Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet

NCT05351294 | Suspended Phase 3 DMC FDA Drug

• 2 other identifiers: 002168Pro2021002435
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 6

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 standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.

Conditions

Radiation Therapy; Metastatic Cancer

Keywords

Quality of Life; Palliative Care and Supportive Care

Outcome Measures

Primary Outcomes (1)

• 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.

  At Six Months

Secondary Outcomes (2)

• Levels of HRQL

  12 Months

• Health Index Score

  12 months

Other Outcomes (2)

• Vertical Visual Analogue Scale (EQ visual analogue scale)

  12 months

• EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)

  12 months

Study Arms (2)

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.

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.

Combination Product: Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Interventions

Questionnaires OTHER

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.

Arm 1

Early Radiation Oncology Involvement Alongside Standard Oncologic Care COMBINATION_PRODUCT

Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (6)

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Malcolm David Mattes, MD

Newark, New Jersey, 07103, United States

Location

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Malcolm Mattes, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 28, 2022
• Study Start: July 13, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)