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Radiation Therapy

High Dose Re-Irradiation for Cancer (REDIRICT Trial)

N/A

Recruiting

Led By Elizabeth Gore, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s)

Be older than 18 years old

Must not have

ECOG Performance status ≥ 3

Patients receiving low dose radiation for symptom management only

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a consistent approach to give radiation to tumors and analyze its effects on nearby organs.

Who is the study for?

Adults (18+) with stage I-IV solid tumors previously treated with radiation, now needing high dose re-irradiation. Must have a life expectancy of at least 6 months, an ECOG score of 0-2 indicating they are able to perform daily activities, and acceptable organ function as shown by specific lab values. Pregnant women or those not using contraception are excluded.

What is being tested?

The trial is testing a standardized approach for re-irradiating patients who have had prior radiation therapy. It focuses on advanced imaging techniques for planning treatment and monitoring the effects on organs at risk (like arteries, nerves, spinal cord) over time.

What are the potential side effects?

Potential side effects include damage to nearby organs or tissues due to high doses of radiation such as inflammation in affected areas, changes in organ function (e.g., gastrointestinal issues), fatigue, skin reactions where the radiation is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and getting high dose radiation in an area previously treated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need help with my daily activities due to my health condition.

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I am receiving low dose radiation just for symptom relief.

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I have severe or uncontrolled health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Organ-specific grade 3 toxicity.

Organ-specific grade 4 toxicity.

Organ-specific grade 5 toxicity.

Side effects data

From 2024 Phase 2 trial • 60 Patients • NCT03661723

40%

Fatigue

33%

Headache

27%

Dysphasia

23%

Lymphocyte count decreased

17%

Muscle weakness left-sided

13%

Hypophosphatemia

13%

Hyperglycemia

13%

Confusion

13%

Hypertension

10%

Fall

10%

Urinary tract infection

10%

Memory impairment

10%

Weight gain

10%

Muscle weakness right-sided

Upper respiratory infection

Generalized muscle weakness

Dysarthria

Edema cerebral

Hyperthyroidism

Nausea

Flu like symptoms

Gait disturbance

Sinusitis

Seizure

Agitation

Urinary incontinence

Skin infection

Surgical and medical procedures - Other, specify: Craniotomy revision with hardware removal

Wound complication

Wound dehiscence

Surgical and medical procedures - Other, specify: Craniotomy for tumor resection

Thromboembolic event

Vomiting

Fever

Papilledema

Intracranial hemorrhage

Stroke

Nervous system disorders - Other, specify: Left facial droop

100%

80%

60%

40%

20%

Study treatment Arm

COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)

COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)

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: Cancer patients receiving definitive radiation therapy with overlap of a previously treated fieldExperimental Treatment1 Intervention

This is a re-irradiation study in solid tumor patients receiving definitive high dose radiation therapy to treatment volumes that include overlap with previously irradiated organs at risk.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Re-irradiation

2018

Completed Phase 2

~60

0 / 4Eligibility criteria met