← Back to Search

Radiation Therapy

Stereotactic Radiosurgery Timing for Brain Metastasis

Phase 3

Recruiting

Led By Debra N Yeboa

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single fraction and =< 7 cm for multifraction therapy

Documented history of malignancy

Must not have

Patients who have received prior radiation therapy to the brain for any reason

The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trialcompares giving high-dose radiation to brain tumors before or after surgery to see which works better for treating brain metastases.

Who is the study for?

This trial is for cancer patients with brain metastases who can undergo surgery and stereotactic radiosurgery (SRS). They should have a primary lesion size within specified limits, be in good enough health as measured by performance scores, and not have had previous brain radiation. Pregnant or breastfeeding women are excluded.

What is being tested?

The study compares the effectiveness of SRS when done before surgery versus after surgery in treating brain tumors from metastasized cancer. It's a phase III trial to determine which timing works best for high-dose radiation focused on the tumors.

What are the potential side effects?

While specific side effects aren't listed here, SRS generally may cause headaches, swelling at treatment site, fatigue, nausea, hair loss at the treated area, and short-term memory issues among others.

Eligibility Criteria

Inclusion Criteria

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

Select...

My main cancer area is 4 cm or less for one treatment, or 7 cm or less for multiple treatments.

Select...

I have a documented history of cancer.

Exclusion Criteria

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

Select...

I have had radiation therapy to my brain before.

Select...

My primary cancer is either small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Leptomeningeal disease (LMD)-free rate

Secondary study objectives

Distant brain control

Local control rate

Overall survival (OS)

Other study objectives

Delta radiomics

Health outcomes questionnaire

Neurocognitive function measured by COWA questionnaire

+4 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702

32%

Fatigue

28%

Lymphocyte count decreased

24%

Cough

20%

Back pain

20%

Rash acneiform

16%

Anorexia

16%

Dry skin

16%

Hyperglycemia

16%

Rash maculo-papular

12%

Aspartate aminotransferase increased

12%

Non-cardiac chest pain

12%

Diarrhea

12%

Dyspepsia

12%

Headache

12%

Nausea

12%

Pain

12%

Pain in extremity

Urinary tract pain

Weight loss

Watering eyes

Myalgia

Wheezing

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Sore throat

Vomiting

Urinary urgency

Urinary tract infection

Upper respiratory infection

White blood cell decreased

Skin infection

Insomnia

Lethargy

Infusion site extravasation

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (pre-operative SRS)Experimental Treatment3 Interventions

Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Group II: Group II (post-operative SRS)Active Control3 Interventions

Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

0 / 4Eligibility criteria met