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Trial Title: Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

NCT ID: NCT05946213

Condition: Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: External Beam Radiation Therapy
Description: Undergo EBRT
Arm group label: Arm II (EBRT)

Other name: Definitive Radiation Therapy

Other name: EBRT

Other name: External Beam Radiation

Other name: External Beam Radiotherapy

Other name: External Beam Radiotherapy (conventional)

Other name: External Beam RT

Other name: external radiation

Other name: External Radiation Therapy

Other name: external-beam radiation

Other name: Radiation, External Beam

Other name: Teleradiotherapy

Other name: Teletherapy

Other name: Teletherapy Radiation

Intervention type: Radiation
Intervention name: Stereotactic Body Radiation Therapy
Description: Undergo SBRT
Arm group label: Arm I (SBRT)

Other name: SABR

Other name: SBRT

Other name: Stereotactic Ablative Body Radiation Therapy

Summary: This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Detailed description: PRIMARY OBJECTIVE: I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. SECONDARY OBJECTIVES: I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms. II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains). III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain). IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms. V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms. VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms. VIII. To compare overall survival between treatment arms. EXPLORATORY OBJECTIVES: I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms. II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks. ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks. Patients are followed up every 6 months for 5 years.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer - High-risk disease defined as having at least one or more of the following: - cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed - The patient's prostate specific antigen (PSA) > 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors - Gleason Score of 8-10 - Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm - Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan - No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute - Age >= 18 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 - No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - No prior radical prostatectomy - Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =< 185 days prior to registration - Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kaiser Permanente-Deer Valley Medical Center

Address:
City: Antioch
Zip: 94531
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Dublin

Address:
City: Dublin
Zip: 94568
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Fremont

Address:
City: Fremont
Zip: 94538
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Fresno Cancer Center

Address:
City: Fresno
Zip: 93720
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Fresno

Address:
City: Fresno
Zip: 93720
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Modesto

Address:
City: Modesto
Zip: 95356
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Oakland-Broadway

Address:
City: Oakland
Zip: 94611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Oakland

Address:
City: Oakland
Zip: 94611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: UC Irvine Health/Chao Family Comprehensive Cancer Center

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-827-8839
Email: ucstudy@uci.edu

Investigator:
Last name: Steven N. Seyedin
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Rancho Cordova Cancer Center

Address:
City: Rancho Cordova
Zip: 95670
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente- Marshall Medical Offices

Address:
City: Redwood City
Zip: 94063
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Richmond

Address:
City: Richmond
Zip: 94801
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Rohnert Park Cancer Center

Address:
City: Rohnert Park
Zip: 94928
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Roseville

Address:
City: Roseville
Zip: 95661
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: The Permanente Medical Group-Roseville Radiation Oncology

Address:
City: Roseville
Zip: 95678
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Downtown Commons

Address:
City: Sacramento
Zip: 95814
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-South Sacramento

Address:
City: Sacramento
Zip: 95823
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: South Sacramento Cancer Center

Address:
City: Sacramento
Zip: 95823
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-San Francisco

Address:
City: San Francisco
Zip: 94115
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Santa Teresa-San Jose

Address:
City: San Jose
Zip: 95119
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente San Leandro

Address:
City: San Leandro
Zip: 94577
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser San Rafael-Gallinas

Address:
City: San Rafael
Zip: 94903
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Medical Center - Santa Clara

Address:
City: Santa Clara
Zip: 95051
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Santa Rosa

Address:
City: Santa Rosa
Zip: 95403
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Cancer Treatment Center

Address:
City: South San Francisco
Zip: 94080
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-South San Francisco

Address:
City: South San Francisco
Zip: 94080
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Stockton

Address:
City: Stockton
Zip: 95210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente Medical Center-Vacaville

Address:
City: Vacaville
Zip: 95688
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Vallejo

Address:
City: Vallejo
Zip: 94589
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Kaiser Permanente-Walnut Creek

Address:
City: Walnut Creek
Zip: 94596
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-642-4691
Email: Kpoct@kp.org

Investigator:
Last name: Samantha A. Seaward
Email: Principal Investigator

Facility:
Name: Helen F Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Medical Oncology Hematology Consultants PA

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Jupiter Medical Center

Address:
City: Jupiter
Zip: 33458
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 561-745-5768

Investigator:
Last name: Nathan Tennyson
Email: Principal Investigator

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 312-695-1301
Email: cancer@northwestern.edu

Investigator:
Last name: Sean Sachdev
Email: Principal Investigator

Facility:
Name: Decatur Memorial Hospital

Address:
City: Decatur
Zip: 62526
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Northwestern Medicine Cancer Center Kishwaukee

Address:
City: DeKalb
Zip: 60115
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 630-352-5360
Email: Donald.Smith3@nm.org

Investigator:
Last name: Sean Sachdev
Email: Principal Investigator

Facility:
Name: Crossroads Cancer Center

Address:
City: Effingham
Zip: 62401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Northwestern Medicine Cancer Center Delnor

Address:
City: Geneva
Zip: 60134
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 630-352-5360
Email: Donald.Smith3@nm.org

Investigator:
Last name: Sean Sachdev
Email: Principal Investigator

Facility:
Name: Memorial Hospital East

Address:
City: Shiloh
Zip: 62269
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 314-747-9912
Email: dschwab@wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Memorial Medical Center

Address:
City: Springfield
Zip: 62781
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-528-7541
Email: pallante.beth@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Northwestern Medicine Cancer Center Warrenville

Address:
City: Warrenville
Zip: 60555
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 630-352-5360
Email: Donald.Smith3@nm.org

Investigator:
Last name: Sean Sachdev
Email: Principal Investigator

Facility:
Name: McFarland Clinic - Ames

Address:
City: Ames
Zip: 50010
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com

Investigator:
Last name: Joseph J. Merchant
Email: Principal Investigator

Facility:
Name: Saint Joseph Mercy Hospital

Address:
City: Ann Arbor
Zip: 48106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Saint Joseph Mercy Brighton

Address:
City: Brighton
Zip: 48114
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Saint Joseph Mercy Canton

Address:
City: Canton
Zip: 48188
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Saint Joseph Mercy Chelsea

Address:
City: Chelsea
Zip: 48118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Mary Mercy Livonia Hospital

Address:
City: Livonia
Zip: 48154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Saint Luke's Hospital of Duluth

Address:
City: Duluth
Zip: 55805
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-249-7825
Email: kdean@slhduluth.com

Investigator:
Last name: Steven R. Bonin
Email: Principal Investigator

Facility:
Name: Saint Francis Medical Center

Address:
City: Cape Girardeau
Zip: 63703
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 573-334-2230
Email: sfmc@sfmc.net

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at West County Hospital

Address:
City: Creve Coeur
Zip: 63141
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center-South County

Address:
City: Saint Louis
Zip: 63129
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Missouri Baptist Medical Center

Address:
City: Saint Louis
Zip: 63131
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 314-996-5569

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at Christian Hospital

Address:
City: Saint Louis
Zip: 63136
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Siteman Cancer Center at Saint Peters Hospital

Address:
City: Saint Peters
Zip: 63376
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-600-3606
Email: info@siteman.wustl.edu

Investigator:
Last name: Hiram A. Gay
Email: Principal Investigator

Facility:
Name: Benefis Healthcare- Sletten Cancer Institute

Address:
City: Great Falls
Zip: 59405
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Westchester Medical Center

Address:
City: Valhalla
Zip: 10595
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-339-5294
Email: Roster@nrgoncology.org

Investigator:
Last name: Mark D. Hurwitz
Email: Principal Investigator

Facility:
Name: Aultman Health Foundation

Address:
City: Canton
Zip: 44710
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 330-363-7274
Email: ClinicalReserachDept@aultman.com

Investigator:
Last name: Steven E. Olyejar
Email: Principal Investigator

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Investigator:
Last name: Tyler Gunter
Email: Principal Investigator

Facility:
Name: Christiana Care Health System-Concord Health Center

Address:
City: Chadds Ford
Zip: 19317
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Reading Hospital

Address:
City: West Reading
Zip: 19611
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 610-988-9323

Investigator:
Last name: Michael L. Haas
Email: Principal Investigator

Facility:
Name: Langlade Hospital and Cancer Center

Address:
City: Antigo
Zip: 54409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-623-9869
Email: Juli.Alford@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Ascension Saint Mary's Hospital

Address:
City: Rhinelander
Zip: 54501
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-847-2353
Email: Beth.Knetter@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Ascension Saint Michael's Hospital

Address:
City: Stevens Point
Zip: 54481
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-847-2353
Email: Beth.Knetter@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Aspirus Regional Cancer Center

Address:
City: Wausau
Zip: 54401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-405-6866

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Aspirus Cancer Care - Wisconsin Rapids

Address:
City: Wisconsin Rapids
Zip: 54494
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-422-7718

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Start date: November 13, 2023

Completion date: March 31, 2041

Lead sponsor:
Agency: NRG Oncology
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: NRG Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05946213

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