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

NCT05351294 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

OTHER

Questionnaires

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.

COMBINATION_PRODUCT

Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Early Radiation Oncology Involvement Alongside Standard Oncologic Care

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Malcolm Mattes, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2026-12-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351294 on ClinicalTrials.gov