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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My small cell lung cancer is classified as either limited or extensive stage.
Select...
My cancer responded to chemotherapy in the last 56 days.
Select...
I can take care of myself and am up more than 50% of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HVLT-R delayed recall deterioration status, defined using the Reliable Change Index (RCI) (Phase III)
Intracranial relapse rate (Phase II)
Secondary outcome measures
Cost-effectiveness as measured by the EQ-5D (Phase III)
Incidence of adverse events (AEs), as measured by the CTCAE v.4 (Phase III)
Intracranial relapse rate (Phase III)
+4 moreOther outcome measures
White matter injury and hippocampal volume on neurocognitive function
Side effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (PCI with HA using IMRT)Experimental Treatment4 Interventions
Patients undergo PCI with HA using IMRT daily for 2 weeks.
Group II: Arm I (PCI using 3DCRT)Active Control4 Interventions
Patients undergo PCI using 3DCRT daily for 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,735 Total Patients Enrolled
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,509 Total Patients Enrolled
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,434 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have a magnetic resonance imaging (MRI) scan if you have metal implants or severe claustrophobia.I finished my chemotherapy between 1 to 8 weeks ago.I have extensive-stage small cell lung cancer and may get chest radiation after chemotherapy.My small cell lung cancer is classified as either limited or extensive stage.I have had radiotherapy to my head or neck, excluding T1 glottic cancer, with overlapping radiation fields.I am a woman who can have children and I had a negative pregnancy test within the last 2 weeks.I will receive chemotherapy or cancer drugs during my brain radiation.I have not had any cancer other than non-melanoma skin cancer in the last 5 years.I am HIV positive with a CD4 count below 200.I can take care of myself and am up more than 50% of my waking hours.My cancer responded to chemotherapy in the last 56 days.I have completed specific brain function tests recently.Participants must have a memory test score higher than 2 at the beginning of the study.I am currently taking or allowed to take atezolizumab.I am not pregnant, breastfeeding, and if capable of childbearing or fathering children, I agree to use contraception.My cancer is a high-grade neuroendocrine or mixed small/large cell type.My last imaging after chemotherapy was within the last 56 days.You have a serious ongoing health condition.My small cell lung cancer was confirmed by a test within the last 250 days.You have signs of cancer spreading to the brain or spinal cord.There are unusual changes in the ventricles of your brain when seen on a scan.You need to have a special MRI scan with contrast dye within 56 days before joining the study.I speak English or French as my primary language.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (PCI using 3DCRT)
- Group 2: Arm II (PCI with HA using IMRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals has this experiment been designed to meet?
"The purpose of this trial is to measure the intracranial relapse rate over a 6-month period. Secondary outcomes include patient-reported quality of life, as measured by the EORTC QLQ-C30 and BN20, cognitive function decline at 3, 6, 12, 18 and 24 months, and time to neurocognitive failure."
Answered by AI
Is this clinical trial taking place in several locations throughout Canada?
"To name a few of the 100 other locations, this trial is enrolling patients at Christiana Care Health System-Concord Health Center in Chadds Ford, Pennsylvania, Norris Cotton Cancer Center-North in Saint Johnsbury, Vermont, and University Health Network-Princess Margaret Hospital in Toronto, Ontario."
Answered by AI
Is this research still enrolling participants?
"This research is not recruiting patients at the moment, however according to clinicaltrials.gov this study was last updated on 11/1/2022. It's possible that patient recruitment will open up again in the future. There are 3,959 other ongoing trials that are currently looking for patients."
Answered by AI
Who else is applying?
What site did they apply to?
Saint Luke's Hospital of Kansas City
What portion of applicants met pre-screening criteria?
Did not meet criteria
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