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Early Radiation Therapy for Cancer

Phase 3
Recruiting
Led By Malcolm Mattes, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Clinical or pathological diagnosis of metastatic disease, for which curative intent treatment is not feasible and treatment goals are palliative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare the quality of life of cancer patients receiving early radiation therapy alongside standard care to those receiving only standard care.

Who is the study for?
Adults over 18 with cancer outside the brain, receiving or planning to receive systemic therapy, and not expected to be cured. They must understand and consent to the study, have a life expectancy of 6-24 months but not longer than that for certain cancers. Excluded are those with specific types of responsive cancers, leukemia, CNS cancers, uncontrolled illnesses, pregnant/breastfeeding women, cognitively impaired adults without decision-making capacity.Check my eligibility
What is being tested?
The trial is testing if adding early radiation oncology consultations to standard cancer care improves quality of life at six months compared to just standard care alone. This is measured using a quality-of-life questionnaire (EORTC QLQ-C30).See study design
What are the potential side effects?
Since this trial involves questionnaires and early consultation rather than new medications or treatments directly administered to patients as part of the intervention being tested, there are no direct side effects from these interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has spread and cannot be cured, so my treatment is aimed at comfort.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My cancer is confirmed by tests and did not start in my brain or spinal cord.
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I am currently on or planning to start cancer treatment using drugs.
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I am in another clinical trial but it doesn't forbid radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure of Health-related quality of life (HRQL) at six months
Secondary outcome measures
Health Index Score
Levels of HRQL
Other outcome measures
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Vertical Visual Analogue Scale (EQ visual analogue scale)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
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.
Group II: Arm 1Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
426 Previous Clinical Trials
63,989 Total Patients Enrolled
Malcolm Mattes, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
4 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently enrolling new participants?

"The trial is still recruiting patients, according to the most recent information available on clinicaltrials.gov. This particular study was posted on July 13th, 2022 and updated on September 26th of the same year."

Answered by AI

What are the risks associated with Early Radiation Oncology Involvement Alongside Standard Oncologic Care?

"Early Radiation Oncology Involvement Alongside Standard Oncologic Care is a Phase 3 trial, which means that there is data supporting its efficacy and safety. Our team rates it as a 3 on a scale of 1 to 3."

Answered by AI
~76 spots leftby Dec 2025