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Radiation Therapy

Stereotactic Radiation for Lung Cancer with Brain Metastases

N/A

Waitlist Available

Led By Ayal A Aizer, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases

Age >=18 years at diagnosis of brain metastases

Must not have

Participants who cannot receive gadolinium

Participants with stage IV-V chronic kidney disease or end stage renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until death or loss to follow up, up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing:

Who is the study for?

This trial is for adults with small cell lung cancer who have 1-10 brain metastases visible on MRI. It's open to those who've had previous systemic therapy and possibly surgery for brain metastases, but not to those who've had prior brain radiation, can't receive gadolinium, have widespread leptomeningeal disease, more than six brain lesions, received preventive cranial radiation, severe kidney disease or inadequate mental capacity.

What is being tested?

The study tests stereotactic radiation—a precise type of radiation that targets individual tumors without affecting the surrounding brain—against traditional whole-brain radiation in treating patients with small cell lung cancer that has spread to the brain.

What are the potential side effects?

Stereotactic radiation may cause headaches, fatigue, hair loss at treatment site, skin irritation around the targeted area and temporary swelling or more serious side effects like changes in cognitive function depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer has spread to my brain.

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I was 18 or older when my brain cancer was diagnosed.

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I had surgery to remove brain metastases but haven't started follow-up radiation.

Exclusion Criteria

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

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I cannot receive gadolinium.

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My kidney function is severely reduced or I am on dialysis.

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My cancer has spread to the lining of my brain and spinal cord.

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I have more than 6 confirmed brain tumors.

Select...

I am unable to complete questionnaires due to mental capacity.

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I have had radiation to my head to prevent cancer spread to the brain.

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I have had radiation treatment for brain cancer spread.

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My tumor is larger than 5 cm and has not been removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until death or loss to follow up, up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until death or loss to follow up, up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and until death or loss to follow up, 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

Death due to progressive neurologic disease

Secondary study objectives

Ability to complete activities of daily living

Perinatal death

Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course

+13 more

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648

67%

Constipation

67%

Hypotension

67%

Cough

67%

Nausea

33%

Proctitis

33%

Seizure

33%

Pyrexia

33%

Haemorrhoids

33%

Hypokalaemia

33%

Abdominal pain

33%

Pain in extremity

33%

Rectal haemorrhage

33%

Urinary incontinence

33%

Vomiting

33%

Vision blurred

33%

Dyspnoea

33%

Micturition urgency

33%

Pollakiuria

33%

Decreased appetite

33%

Hyperglycaemia

33%

Traumatic haematoma

33%

Hyperchloraemia

33%

Fatigue

33%

Pain

33%

Mood altered

33%

Sepsis

33%

Nocturia

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 Dose Level 1

Phase 2 Cohort 2b

Phase 2 Cohort 2a

Phase 1 Dose Level 2

Phase 1 Dose Level 3

Phase 2 Cohort 2c

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: Stereotactic RadiationExperimental Treatment1 Intervention

* Stereotactic radiation will begin within 14 days of the MRI used for radiation planning * Lesions \<2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction * Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction * Lesions \>3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiation

2014

Completed Phase 2

~170

0 / 11Eligibility criteria met