SUSPENDED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-13

Study Completion:2027-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05351294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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. -

Inclusion Criteria

Exclusion Criteria

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.

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. -

Contacts and Locations

Principal Investigator

Malcolm Mattes, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, 07302

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903

United States

Malcolm David Mattes, MD

Newark, New Jersey, 07103

United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Malcolm Mattes, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-13

Study Completion Date2027-12-30

Study Record Updates

Study Start Date2023-07-13

Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

Quality of Life
Palliative Care and Supportive Care

Additional Relevant MeSH Terms

Radiation Therapy
Metastatic Cancer