Prostate Cancer Clinical Trial

S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.

View Full Description

Full Description

OBJECTIVES:

Primary

To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).

Secondary

To assess the overall survival and objective progression-free survival of this group of patients.
To assess PSA partial response.
To evaluate the qualitative and quantitative toxicity of abiraterone acetate.

OUTLINE: This is a multicenter study.

Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.

After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate

Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)

Must have at least one of the following:

Visceral disease (liver, lung, other viscera)
Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
Distant lymph node disease (e.g., above the aortic bifurcation, etc.)
No small cell or neuroendocrine prostate cancer

Patients must be receiving ADT (e.g., gonadotropin-releasing hormone [GNRH] antagonist, with or without antiandrogen) prior to entering this study

Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT
Bilateral surgical orchiectomy is also acceptable

Suboptimal response to ADT induction as defined by the following criteria:

Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT

PSA of > 4 ng/mL must be observed between 6-12 months after the initiation of ADT

Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28 days of registration

The PSA must be obtained after any applicable antiandrogen washout period
If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen
Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is > 4 ng/mL by month 12, in order to be eligible
If the PSA is rising and they are on an antiandrogen, formal antiandrogen washout must be performed (4 weeks for flutamide and 6 weeks for bicalutamide and nilutamide with no evidence of a falling PSA after washout)
No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy
Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic CT scan) within 28 days prior to registration
Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to registration

No patients with a history of brain metastases or who currently have treated or untreated brain metastases

Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
ANC ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 10 g/dL
Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)
AST and ALT < 1.5 times ULN
Potassium ≥ 3.5 mmol/L
Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to registration

Patients must have controlled blood pressure defined as systolic blood pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg

Patients with a history of hypertension are eligible provided blood pressure is controlled by anti-hypertensive treatment
Patients who have partners of child-bearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last study drug administration
Must be able to take oral medication without crushing, dissolving, or chewing tablets
Patients must not have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of abiraterone acetate

No other prior malignancy is allowed except for any of the following:

Adequately treated basal cell or squamous cell skin cancer
Adequately treated stage I or II cancer from which the patient is currently in complete remission
Any other cancer from which the patient has been disease-free for 5 years

No patients with active or symptomatic viral hepatitis or chronic liver disease

No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

No history of NYHA class III or IV heart failure

Patients must have LVEF ≥ 50%
No known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist therapy (related to previous surgery or radiation) are eligible provided they finished this therapy at least two years prior to registration

Prior enrollment to SWOG-S0925 (either arm) is not exclusionary
At least 6 weeks since prior and no concurrent finasteride or dutasteride
At least 28 days since prior radiotherapy or surgery and recovered
At least 4 weeks since prior investigational products

At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA

No other concurrent oral antiandrogen
No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer
No prior or concurrent ketoconazole for the treatment of prostate cancer
Not requiring more than 10 mg a day of prednisone for another medical indication
Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy, surgery, or radiotherapy during protocol treatment
No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone, PC-SPES, or spironolactone
No concurrent antifungal medication (e.g., fluconazole or itraconazole)
No medications that alter cardiac conduction
No prior Provenge (sipuleucel-T)

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01309672

Recruitment Status:

Active, not recruiting

Sponsor:

Southwest Oncology Group

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There are 178 Locations for this study

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NEA Medical Clinic - East Matthews
Jonesboro Arkansas, 72401, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Highlands Oncology Group - Springdale
Rogers Arkansas, 72758, United States
Kaiser Permanente - Deer Valley
Antioch California, 94531, United States
Kaiser Permanente - Fremont
Fremont California, 94538, United States
Kaiser Permanente Fresno Medical Center
Fresno California, 93720, United States
Kaiser Permanente Medical Center - Hayward
Hayward California, 94545, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville California, 95901, United States
Kaiser Permanente Medical Center - Oakland
Oakland California, 94611, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City California, 94063, United States
Kaiser Permanente Medical Center - Richmond
Richmond California, 94801, United States
Kaiser Permanente Medical Center - Roseville
Roseville California, 95661, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento California, 95823, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento California, 95825, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco California, 94115, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose California, 95119, United States
Kaiser Foundation Hospital - San Rafael
San Rafael California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara California, 95051, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa California, 95403, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente Medical Facility - Stockton
Stockton California, 95210, United States
Tahoe Forest Cancer Center
Truckee California, 96161, United States
Kaiser Permanente Medical Center - Vacaville
Vacaville California, 95688, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek California, 94596, United States
San Luis Valley Regional Medical Center
Alamosa Colorado, 81101, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora Colorado, 80045, United States
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs Colorado, 80909, United States
Shaw Regional Cancer Center
Edwards Colorado, 81632, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins Colorado, 80528, United States
Valley View Hospital Cancer Center
Glenwood Springs Colorado, 81601, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
Montrose Memorial Hospital Cancer Center
Montrose Colorado, 81401, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
M.D. Anderson Cancer Center at Orlando
Orlando Florida, 32806, United States
Kapiolani Medical Center at Pali Momi
'Aiea Hawaii, 96701, United States
Oncare Hawaii, Incorporated - Pali Momi
'Aiea Hawaii, 96701, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu Hawaii, 96817, United States
Kuakini Medical Center
Honolulu Hawaii, 96817, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
Honolulu Hawaii, 96819, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Castle Medical Center
Kailua Hawaii, 96734, United States
Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise Idaho, 83712, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland Idaho, 83619, United States
St. Joseph Regional Medical Center
Lewiston Idaho, 83501, United States
Mountain States Tumor Institute - Meridian
Meridian Idaho, 83642, United States
Saint Luke's Mountain States Tumor Institute
Nampa Idaho, 83686, United States
Mountain States Tumor Institute at St. Luke's
Twin Falls Idaho, 83301, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
Normal Illinois, 61761, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport Iowa, 52803, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
St. Rose Ambulatory and Surgery Center
Great Bend Kansas, 67530, United States
Hays Medical Center
Hays Kansas, 67601, United States
Hutchinson Hospital Corporation
Hutchinson Kansas, 67502, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Kansas City Cancer Centers - West
Kansas City Kansas, 66112, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Kansas City Cancer Centers - Southwest
Overland Park Kansas, 66210, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Mount Carmel Regional Cancer Center
Pittsburg Kansas, 66762, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67401, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Kansas City Cancer Center - Shawnee Mission
Shawnee Mission Kansas, 66204, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66606, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
Tulane Cancer Center Office of Clinical Research
Alexandria Louisiana, 71315, United States
Hematology-Oncology Clinic
Baton Rouge Louisiana, 70809, United States
Cancer Center of Acadiana at Lafayette General Medical Center
Lafayette Louisiana, 70503, United States
Highland Clinic
Shreveport Louisiana, 71105, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport Louisiana, 71130, United States
Caritas Holy Family Hospital
Methuen Massachusetts, 01844, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Bay Regional Medical Center
Bay City Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
McLaren Cancer Institute
Flint Michigan, 48532, United States
Singh and Arora Hematology Oncology, PC
Flint Michigan, 48532, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
Great Lakes Cancer Institute - Lapeer Campus
Lapeer Michigan, 48446, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
Clemens Regional Medical Center
Mount Clemens Michigan, 48043, United States
Mercy General Health Partners
Muskegon Michigan, 49444, United States
Northern Michigan Hospital
Petoskey Michigan, 49770, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City Michigan, 49677, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
University of Mississippi Cancer Clinic
Jackson Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Truman Medical Center - Hospital Hill
Kansas City Missouri, 64108, United States
Kansas City Cancer Centers - South
Kansas City Missouri, 64131, United States
Kansas City Cancer Centers - North
Kansas City Missouri, 64154, United States
Kansas City Cancer Centers - East
Lee's Summit Missouri, 64064, United States
Midwest Hematology Oncology Group, Incorporated
Saint Louis Missouri, 63109, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59102, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Valley Hospital - Ridgewood
Ridgewood New Jersey, 07450, United States
Hematology Oncology Associates, PC
Albuquerque New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States
New Mexico Cancer Care Associates
Santa Fe New Mexico, 87505, United States
Falck Cancer Center at Arnot Ogden Medical Center
Elmira New York, 14905, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown New York, 10940, United States
Winthrop University Hospital
Mineola New York, 11501, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York New York, 10025, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Iredell Memorial Hospital
Statesville North Carolina, 28677, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Knox Community Hospital
Mount Vernon Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Southern Ohio Medical Center Cancer Center
Portsmouth Ohio, 45662, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Mount Carmel St. Ann's Cancer Center
Westerville Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
McLeod Regional Medical Center
Florence South Carolina, 29501, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport Tennessee, 37662, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Baylor University Medical Center - Houston
Houston Texas, 77030, United States
Ben Taub General Hospital
Houston Texas, 77030, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Houston Texas, 77030, United States
Veterans Affairs Medical Center - Houston
Houston Texas, 77030, United States
UMC Southwest Cancer and Research Center
Lubbock Texas, 79415, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
Providence Centralia Hospital
Centralia Washington, 98531, United States
Providence Regional Cancer Partnership
Everett Washington, 98201, United States
St. Francis Hospital
Federal Way Washington, 98003, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia Washington, 98506, United States
Good Samaritan Cancer Center
Puyallup Washington, 98372, United States
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma Washington, 98405, United States
Allenmore Hospital
Tacoma Washington, 98405, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma Washington, 98405, United States
St. Clare Hospital
Tacoma Washington, 98499, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT01309672

Recruitment Status:

Active, not recruiting

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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