Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients With Limited Stage or Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Carcinoma, Limited Stage Small Cell Lung Carcinoma
About this trial
This is an interventional supportive care trial for Extensive Stage Small Cell Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration
- High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
Patients must have received chemotherapy and be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. Note:
- Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
- For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan (see section 11.3 regarding axial T2/FLAIR sequence). To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm. Sites may contact the Imaging Co-Chairs for further information or assistance if needed.
- This MRI must be obtained within 56 days prior to Step 1 registration. Note: The MRI study is mandatory irrespective of randomization to the experimental or control arm of this study.
Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:
- History/physical examination;
- CT of the chest and abdomen with contrast (does not have to be done if the patient has had a PET/CT scan prior to initiating chemotherapy or thoracic radiotherapy);
- MRI of the brain with contrast or diagnostic head CT with contrast;
- For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC.
After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy. Repeat PET/CT or bone scan is not required. Patients must have:
- History/physical examination within 30 days of Step 1 registration;
- No CNS metastases (Repeat MRI required; see Section 3.2.3 for details) within 56 days prior to Step 1 registration;
- No progression in any site;
Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration.
- If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment.
- Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression.
- Zubrod performance status 0-2
- Women of childbearing potential and male participants must practice adequate contraception
- Women of childbearing potential must have a negative qualitative serum pregnancy test =< 2 weeks prior to study entry
- Patients who are primary English or French speakers are eligible
- Patients must sign a study-specific informed consent prior to study entry
- PRIOR TO STEP 2 REGISTRATION
- The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (Parts A and B), and COWA. The neurocognitive assessments will be uploaded into the NRG Oncology RAVE System for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days, a notification email will be sent to the site to proceed to Step 2 registration. At minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible.
- Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall
Exclusion Criteria:
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
- Radiographic evidence of CNS metastases
- Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Planned concurrent chemotherapy or anti-tumor agent during PCI
- Concurrent atezolizumab permitted
- Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
- Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled, clinically significant cardiac arrhythmias
HIV positive with CD4 count < 200 cells/microliter;
- Note: Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to Step 1 registration.
- Note: HIV testing is not required for eligibility for this protocol.
- Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Lewis and Faye Manderson Cancer Center
- Banner University Medical Center - Tucson
- Marin General Hospital
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Mercy UC Davis Cancer Center
- Kaiser Permanente Oakland-Broadway
- Saint Joseph Hospital - Orange
- Kaiser Permanente-Rancho Cordova Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente Medical Center - Santa Clara
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Sutter Solano Medical Center/Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Hartford HealthCare - Saint Vincent's Medical Center
- Yale University
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Boca Raton Regional Hospital
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- Broward Health Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Cancer Institute
- Orlando Health Cancer Institute
- Moffitt Cancer Center
- Grady Health System
- Emory University Hospital Midtown
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Northside Hospital
- Northside Hospital-Forsyth
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- The Cancer Center of Hawaii-Pali Momi
- Queen's Medical Center
- The Cancer Center of Hawaii-Liliha
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Saint Luke's Cancer Institute - Twin Falls
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Northwestern Medicine Cancer Center Delnor
- Edward Hines Jr VA Hospital
- Condell Memorial Hospital
- Loyola University Medical Center
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Ascension Saint Vincent Anderson
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Goshen Center for Cancer Care
- IU Health Ball Memorial Hospital
- Saint Luke's Hospital
- Mercy Hospital
- Iowa Methodist Medical Center
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi Hospitals Wichita
- Wesley Medical Center
- University of Kentucky/Markey Cancer Center
- Tulane University Health Sciences Center
- Anne Arundel Medical Center
- University of Maryland Medical Center
- University of Maryland/Greenebaum Cancer Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- MedStar Good Samaritan Hospital
- Johns Hopkins University/Sidney Kimmel Cancer Center
- UM Upper Chesapeake Medical Center
- Central Maryland Radiation Oncology in Howard County
- UM Baltimore Washington Medical Center/Tate Cancer Center
- TidalHealth Richard A Henson Cancer Institute
- TidalHealth Peninsula Regional
- UM Saint Joseph Medical Center
- Lahey Hospital and Medical Center
- Lowell General Hospital
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- McLaren Cancer Institute-Bay City
- Saint Joseph Mercy Brighton
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy Chelsea
- GenesisCare USA - Clarkston
- McLaren Cancer Institute-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- GenesisCare USA - Farmington Hills
- Genesys Hurley Cancer Institute
- McLaren Cancer Institute-Flint
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- West Michigan Cancer Center
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- GenesisCare USA - Macomb
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon Hospital
- McLaren Cancer Institute-Owosso
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- William Beaumont Hospital-Royal Oak
- Lakeland Medical Center Saint Joseph
- William Beaumont Hospital - Troy
- GenesisCare USA - Troy
- Henry Ford West Bloomfield Hospital
- Mayo Clinic Health System in Albert Lea
- Saint Luke's Hospital of Duluth
- Mayo Clinic Health Systems-Mankato
- Abbott-Northwestern Hospital
- Mayo Clinic Radiation Therapy-Northfield
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Saint Francis Medical Center
- Siteman Cancer Center at West County Hospital
- Freeman Health System
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center at North Kansas City Hospital
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Billings Clinic Cancer Center
- Benefis Healthcare- Sletten Cancer Institute
- Community Medical Hospital
- University of Nebraska Medical Center
- Renown Regional Medical Center
- Wentworth-Douglass Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Memorial Sloan Kettering Basking Ridge
- Englewood Hospital and Medical Center
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Bergen
- Virtua Memorial
- Virtua Voorhees
- University of New Mexico Cancer Center
- Northwell Health Imbert Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center - Moses Campus
- New York-Presbyterian/Brooklyn Methodist Hospital
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Arnot Ogden Medical Center/Falck Cancer Center
- Memorial Sloan Kettering Westchester
- Northwell Health/Center for Advanced Medicine
- Lenox Hill Hospital
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- Staten Island University Hospital
- State University of New York Upstate Medical University
- Memorial Sloan Kettering Nassau
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Pineville/LCI-Pineville
- Atrium Health University City/LCI-University
- Atrium Health Cabarrus/LCI-Concord
- Atrium Health Union/LCI-Union
- Atrium Health Cleveland/LCI-Cleveland
- Sanford Bismarck Medical Center
- Sanford Roger Maris Cancer Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Geauga Hospital
- Adena Regional Medical Center
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel Health Center West
- Dayton Physician LLC-Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- Cleveland Clinic Cancer Center Independence
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- Cleveland Clinic Cancer Center Strongsville
- UHHS-Westlake Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- University of Oklahoma Health Sciences Center
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Jefferson Abington Hospital
- Crozer-Keystone Regional Cancer Center at Broomall
- Bryn Mawr Hospital
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Northeast Radiation Oncology Center
- Adams Cancer Center
- Crozer Regional Cancer Center at Brinton Lake
- Geisinger Medical Oncology-Lewisburg
- Riddle Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Temple University Hospital
- Penn State Health Saint Joseph Medical Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- The Radiation Oncology Center-Hilton Head/Bluffton
- Lancaster Radiation Therapy Center
- Rock Hill Radiation Therapy Center
- Rapid City Regional Hospital
- Sanford USD Medical Center - Sioux Falls
- Thompson Cancer Survival Center
- Blount Memorial Hospital
- Vanderbilt University/Ingram Cancer Center
- University of Texas Medical Branch
- M D Anderson Cancer Center
- UTMB Cancer Center at Victory Lakes
- Ogden Regional Medical Center
- Huntsman Cancer Institute/University of Utah
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- Norris Cotton Cancer Center-North
- Virginia Commonwealth University/Massey Cancer Center
- West Virginia University Healthcare
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Mayo Clinic Health System-Eau Claire Clinic
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus
- Ascension Saint Francis - Reiman Cancer Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Mayo Clinic Health System-Franciscan Healthcare
- University of Wisconsin Carbone Cancer Center
- Froedtert Menomonee Falls Hospital
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Marshfield Medical Center-River Region at Stevens Point
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aspirus Regional Cancer Center
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Kingston Health Sciences Centre
- London Regional Cancer Program
- Stronach Regional Health Centre at Southlake
- Ottawa Hospital and Cancer Center-General Campus
- University Health Network-Princess Margaret Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (PCI using 3DCRT)
Arm II (PCI with HA using IMRT)
Patients undergo PCI using 3DCRT daily for 2 weeks.
Patients undergo PCI with HA using IMRT daily for 2 weeks.