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Radiotherapy for Advanced Lung Cancer (DRO2301 Trial)

Phase 2
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Thoracic lung and/or nodal lesion(s) amenable to palliative chest radiotherapy.
a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month, 1 year, and 2 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing the use of radiation therapy in addition to standard treatment for patients with advanced lung cancer to see if it can help improve outcomes."

Who is the study for?
This trial is for adults with Stage IV Non-Small Cell Lung Cancer without certain genetic mutations. They should have a large lung lesion or cancer near critical areas like the esophagus or heart, and not have had previous chest radiotherapy. It's not suitable for those who've received thoracic radiation before.
What is being tested?
The study tests if prophylactic palliative radiotherapy alongside standard treatments can prevent symptoms from worsening in patients with high-risk metastatic lung cancer lesions within the chest area.
What are the potential side effects?
Possible side effects include skin irritation, fatigue, difficulty swallowing, shortness of breath, coughing, and rarely more severe complications such as damage to nearby organs like the heart or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung or lymph node cancer can be treated with chest radiation.
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My lung tumor is larger than 5 cm.
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I need more details to provide an accurate summary.
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My cancer affects the nerve bundle near my shoulder or the main blood vessels in that area.
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My lung cancer does not have specific genetic changes like EGFR, ALK, or ROS1.
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My lung cancer is at stage IV or has returned after treatment aimed at curing it, and I haven't had chest radiation before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month, 1 year, and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month, 1 year, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from symptomatic progression of irradiated thoracic target(s)
Secondary study objectives
Duration of time that patient is maintenance
Freedom from local recurrence of irradiated thoracic target lesion(s)
OS (Kaplan-Meier) (Kaplan-Meier)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prophylactic Palliative RadiotherapyExperimental Treatment1 Intervention
Prophylactic Palliative Radiotherapy

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
869 Previous Clinical Trials
549,714 Total Patients Enrolled
~32 spots leftby Feb 2029
Unbiased ResultsWe believe in providing patients with all the options.
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