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Whole-Brain Radiation Therapy for Small Cell Lung Cancer

Phase 2 & 3
Waitlist Available
Led By Vinai Gondi
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation
Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration
Must not have
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
Planned concurrent chemotherapy or anti-tumor agent during PCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to two years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Who is the study for?
This trial is for adults with small cell lung cancer who've responded to chemotherapy, can undergo MRI scans, and agree to use contraception. It's not for those with prior head/neck radiation (except T1 glottic cancer), CNS metastases, severe comorbidities, other recent cancers (except skin cancer), or untreated HIV.
What is being tested?
The study compares whole-brain radiation therapy effectiveness with and without avoiding the hippocampus—a brain area linked to memory—to see if it reduces cognitive side effects while treating lung cancer that is limited stage or has spread extensively.
What are the potential side effects?
Potential side effects include memory and thinking problems due to high energy x-rays used in brain radiation. Avoiding the hippocampus may reduce these risks but it's unclear if this will affect treatment efficacy.

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 is classified as either limited or extensive stage.
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My cancer responded to chemotherapy in the last 56 days.
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I can take care of myself and am up more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiotherapy to my head or neck, excluding T1 glottic cancer, with overlapping radiation fields.
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I will receive chemotherapy or cancer drugs during my brain radiation.
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I have not had any cancer other than non-melanoma skin cancer in the last 5 years.
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I am HIV positive with a CD4 count below 200.
Select...
I am not pregnant, breastfeeding, and if capable of childbearing or fathering children, I agree to use contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to last known follow-up . maximum follow-up time was 7.2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to last known follow-up . maximum follow-up time was 7.2 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
Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III)
Number of Participants With Intracranial Relapse at 12 Months (Phase II)
Secondary study objectives
Correlation of Quality of Life and Neurocognitive Function (NCF) Measures at 6 Months
Incremental Cost-per Quality-adjusted Life Year (QALY) (Cost-effectiveness as Measured by the EQ-5D (Phase III)
Intracranial Relapse Rate (Phase III)
+20 more
Other study objectives
White matter injury and hippocampal volume on neurocognitive function

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Wound dehiscence
10%
Vascular access complication
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PCI with HA using IMRTExperimental Treatment1 Intervention
PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week.
Group II: PCI using 3DCRTActive Control1 Intervention
Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,770 Total Patients Enrolled
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,506 Total Patients Enrolled
NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,673 Total Patients Enrolled
Vinai GondiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Whole-Brain Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02635009 — Phase 2 & 3
Lung Cancer Research Study Groups: PCI using 3DCRT, PCI with HA using IMRT
Lung Cancer Clinical Trial 2023: Whole-Brain Radiation Therapy Highlights & Side Effects. Trial Name: NCT02635009 — Phase 2 & 3
Whole-Brain Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02635009 — Phase 2 & 3
~42 spots leftby Dec 2025
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