- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124618
Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.
Secondary
- Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
- Determine whether fear of death predicts survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic Scottsdale
-
-
Florida
-
Hollywood, Florida, United States, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
-
Canton, Illinois, United States, 61520
- Graham Hospital
-
Carthage, Illinois, United States, 62321
- Memorial Hospital
-
Effingham, Illinois, United States, 62401
- St. Anthony's Memorial Hospital
-
Eureka, Illinois, United States, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Clinic, PC
-
Galesburg, Illinois, United States, 61401
- InterCommunity Cancer Center of Western Illinois
-
Havana, Illinois, United States, 62644
- Mason District Hospital
-
Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
-
Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, United States, 61761
- Community Cancer Center
-
Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61614
- Proctor Hospital
-
Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
-
Spring Valley, Illinois, United States, 61362
- Valley Cancer Center
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services
-
-
Iowa
-
Ames, Iowa, United States, 50010
- McFarland Clinic, PC
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
-
Des Moines, Iowa, United States, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, United States, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, United States, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50307
- Mercy Capitol Hospital
-
Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, United States, 67901
- Southwest Medical Center
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, United States, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, United States, 67214
- Wesley Medical Center
-
Wichita, Kansas, United States, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, United States, 67214
- CCOP - Wichita
-
Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Jackson, Michigan, United States, 49201
- Foote Memorial Hospital
-
Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, United States, 48154
- St. Mary Mercy Hospital
-
Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital - Monroe
-
Pontiac, Michigan, United States, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, United States, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Warren, Michigan, United States, 48093
- St. John Macomb Hospital
-
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Minnesota
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
-
Lichfield, Minnesota, United States, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, United States, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
Shakopee, Minnesota, United States, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
St Paul, Minnesota, United States, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
-
St. Cloud, Minnesota, United States, 56303
- CentraCare Clinic - River Campus
-
St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Cancer Center
-
St. Paul, Minnesota, United States, 55102
- United Hospital
-
St. Paul, Minnesota, United States, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, United States, 56201
- Willmar Cancer Center at Rice Memorial Hospital
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
Woodbury, Minnesota, United States, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, United States, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, United States, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, United States, 59107-7000
- Billings Clinic - Downtown
-
Billings, Montana, United States, 59107-5100
- Billings Clinic Cancer Center
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, United States, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, United States, 59405
-
Great Falls, Montana, United States, 59405-5309
- Big Sky Oncology
-
Great Falls, Montana, United States, 59405
- Sletten Cancer Institute at Benefis Healthcare
-
Helena, Montana, United States, 59601
- St. Peter's Hospital
-
Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, United States, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, United States, 59801
- Community Medical Center
-
Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, United States, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, United States, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
-
Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, United States, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, United States, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, United States, 68131-2197
- Creighton University Medical Center
-
-
North Carolina
-
Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, United States, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, United States, 58502
- St. Alexius Medical Center Cancer Center
-
Grand Forks, North Dakota, United States, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, United States, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, United States, 45429
- CCOP - Dayton
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, United States, 43420
- Fremont Memorial Hospital
-
Kettering, Ohio, United States, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, United States, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, United States, 43537
- St. Luke's Hospital
-
Middletown, Ohio, United States, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, United States, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, United States, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, United States, 43606
- Toledo Hospital
-
Toledo, Ohio, United States, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, United States, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, United States, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, United States, 43567
- Fulton County Health Center
-
Wright-Patterson Afb, Ohio, United States, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
-
Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
State College, Pennsylvania, United States, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology, Incorporated
-
-
Wisconsin
-
La Crosse, Wisconsin, United States, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
-
Wyoming
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA or IIIB disease
- Must be a candidate for curative radiotherapy
- Not a candidate for other concurrent chemotherapy and radiotherapy
- No surgical treatment available
- No pleural effusion suspected or proven to be malignant
- No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days
PATIENT CHARACTERISTICS:
Age * 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
- ECOG 2 (age 18 to 64 years)
Life expectancy
* At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Pulmonary
- FEV_1 ≥ 1 L
- No idiopathic pulmonary fibrosis
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Magnesium normal
- No uncontrolled infection
- No other severe underlying disease that would preclude study entry
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
- No major psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for NSCLC
Endocrine therapy
* Not specified
Radiotherapy
- No prior therapeutic radiotherapy to the chest
- No concurrent intensity modulated radiotherapy
Other
* No prior epidermal growth factor receptor inhibitors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cetuximab/Radiation
Cetuximab (C225) and Radiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
11-month Survival Rate
Time Frame: From baseline to 11 months.
|
Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone.
11-month survival will be considered synonymous with "success", unless specified otherwise.
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
|
From baseline to 11 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Time
Time Frame: From baseline to up to 3 years
|
Survival time is defined as the time from registration to death due to any cause.
The distribution of survival time will be estimated using the method of Kaplan-Meier.
|
From baseline to up to 3 years
|
Time to Disease Progression
Time Frame: From Baseline to up to 3 years
|
Time to disease progression is defined as the time from registration to documentation of disease progression.
If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
|
From Baseline to up to 3 years
|
Tumor Response (Complete and Partial)
Time Frame: Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration
|
A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart.
All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
|
Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-N0422
- NCI-2012-02664 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000435991 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
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Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States
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Changhai HospitalRecruitingLocalized Prostate CancerChina
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NYU Langone HealthCompletedBreast CancerUnited States