Clinical trial · Interventional
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Radiation Oncology Involvement Alongside Standard Oncologic Care | Combination Product | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- 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.
- interventionNames
- Other: Questionnaires
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available