Anatomic Stage I Breast Cancer AJCC v8NCT03939481
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by SWOG Cancer Research Network at 169 sites in 4 countries.
Trial summary
This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Chemotherapy, Functional Assessment and Questionnaire Administration
- How many people
- 1,336 participants
- Where
- 169 sitesin 4 countries
- Study dates
- 14 May 2019to 1 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer
Who may be able to join
- Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage IV disease are not eligible.
- Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after registration. (Note that docetaxel or paclitaxel may be administered with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.)
- Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study.
- Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.)
- Patients who can complete Patient-Reported Outcome (PRO) instruments in English or Spanish must:
- Agree to complete PROs at all scheduled assessments
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- Complete the baseline PRO forms prior to registration
- Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson?s disease.
- Patients must agree to submit required specimens for defined translational medicine.
- Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient?s consent, specimens must be submitted.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Who cannot join
None listed.
Trial locations and contacts
169 sites in 4 countries.
169 sites in 4 countries
United States166 sites
Hawaii Cancer Care - Savio
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Cleveland Clinic Akron General
Akron, Ohio, 44307
McFarland Clinic PC - Ames
Ames, Iowa, 50010
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Randolph Hospital
Asheboro, North Carolina, 27203
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Waldo County General Hospital
Belfast, Maine, 04915
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, 04005
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Wellmont Medical Associates-Bristol
Bristol, Virginia, 24201
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Centralia Oncology Clinic
Centralia, Illinois, 62801
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Mercy Hospital
Coon Rapids, Minnesota, 55433
Greater Regional Medical Center
Creston, Iowa, 50801
Carle on Vermilion
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
Kaiser Permanente Dublin
Dublin, California, 94568
Essentia Health Cancer Center
Duluth, Minnesota, 55805
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Fairview Southdale Hospital
Edina, Minnesota, 55435
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Little Company of Mary Hospital
Evergreen Park, Illinois, 60805
McLeod Regional Medical Center
Florence, South Carolina, 29506
Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente-Fresno
Fresno, California, 93720
Unity Hospital
Fridley, Minnesota, 55432
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
HaysMed University of Kansas Health System
Hays, Kansas, 67601
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
Edward Hines Jr VA Hospital
Hines, Illinois, 60141
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Saint Joseph London
London, Kentucky, 40741
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, 79430
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Bayhealth Hospital Sussex Campus
Milford, Delaware, 19963
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Trinity Cancer Care Center
Minot, North Dakota, 58701
Trinity Medical Center
Moline, Illinois, 61265
Monticello Cancer Center
Monticello, Minnesota, 55362
Saint Joseph Hospital
Nashua, New Hampshire, 03060
CarolinaEast Medical Center
New Bern, North Carolina, 28561
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Kaiser Permanente-Oakland
Oakland, California, 94611
Olathe Health Cancer Center
Olathe, Kansas, 66061
Desert Regional Medical Center
Palm Springs, California, 92262
Sacred Heart Hospital
Pensacola, Florida, 32504
Phoenixville Hospital
Phoenixville, Pennsylvania, 19460
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Jefferson Healthcare
Port Townsend, Washington, 98368
Kaiser Permanente Northwest
Portland, Oregon, 97227
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Penobscot Bay Medical Center
Rockport, Maine, 04856
Nash General Hospital
Rocky Mount, North Carolina, 27804
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Salina Regional Health Center
Salina, Kansas, 67401
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Essentia Health Sandstone
Sandstone, Minnesota, 55072
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Mercy Hospital Springfield
Springfield, Missouri, 65804
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Lakeview Hospital
Stillwater, Minnesota, 55082
NHRMC Radiation Oncology - Supply
Supply, North Carolina, 28462
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Munson Medical Center
Traverse City, Michigan, 49684
MGC Hematology Oncology-Union
Union, South Carolina, 29379
Carle Cancer Center
Urbana, Illinois, 61801
The Carle Foundation Hospital
Urbana, Illinois, 61801
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Kent Hospital
Warwick, Rhode Island, 02886
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
Associates In Womens Health
Wichita, Kansas, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Rice Memorial Hospital
Willmar, Minnesota, 56201
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401
Winchester Hospital
Winchester, Massachusetts, 01890
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Metro Health Hospital
Wyoming, Michigan, 49519
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Mexico1 site
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080
About this study
Official title: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens.
SECONDARY OBJECTIVES:
- To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population.
II. To assess the incidence of CIPN within one year in this patient population. III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population.
OTHER OBJECTIVES:
- To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.
OUTLINE:
Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Chemotherapy, Functional Assessment, Questionnaire Administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Given chemotherapy regimen
Functional AssessmentOther
Functional and sensory clinician assessments
Questionnaire AdministrationOther
Patient and physician reported responses
| Study group | Role | What they receive |
|---|---|---|
| Observational (non-study chemo, questionnaire, assessments) | Patients receive chemotherapy regimen per treating physician for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires at weeks 4, 8, 12, 24 and 52. Receives: Drug: Chemotherapy; Other: Functional Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Development of Peripheral Neuropathy
Will be measured as an absolute increase of >= 8 points over the baseline chemotherapy-induced peripheral neuropathy (CIPN)-20 sensory neuropathy subscale score. Will be collected before or at the 24-week assessment..
Measured: Up to 24 weeks
Secondary outcomes (9)
CIPN Symptoms
Patients experiencing a treatment change attributed to CIPN symptoms
Measured: Up to 52 weeks
Dose Changes
Dose reductions, delays, and discontinuations of treatment (prior to completing the original treatment plan)
Measured: Up to 52 weeks
Health-related Quality of Life
Assessed using the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). The PROMIS-29 is a well validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
Measured: Up to 52 weeks
Visual Analog Toxicity Score
Assessed using the Visual Analog Toxicity Score. The Visual Analog Toxicity Score is a single question asking the physician to rate how the physician feels the patient's disease and treatment affects their daily life on a scale from 0 (no symptoms and no effect on life) to 10 (severe effects of treatment and patient would rather be dead).
Measured: Up to 52 weeks
Patient Reported Symptom
Assessed using the Patient Reported Symptom Burden Score. The Patient Reported Symptom Score at baseline contains one question to assess how cancer symptoms affect the patient's life (scale 0 [no burden at all] to 10 [a great burden]). At follow-up, the Symptom Burden Score contains five questions: 1) to assess burden of side effects of cancer treatment on life (scale 0 [no burden at all] to 10 [a great burden]), 2) to assess severity of side effects from cancer treatment (scale 0 [no side effects]) to 10 [side effects extremely severe and unbearable]), 3) to assess tolerability of side effects for set time periods (yes/no), 4) to assess level at which treatment would be considered intolerable (scale 0 [side effects not severe at all] to 10 [side effects extremely severe and unbearable]), and 5) to assess the burden of cancer symptoms and treatment symptoms (scale 0 [no burden at all] to 10 [a great burden]).
Measured: Up to 52 weeks
Leisure-time Exercise Habits
Assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). The GSLTPAQ is a brief 4 item self-administered questionnaire of usual leisure-time exercise habits over a typical 7-day period. The Leisure Score Index (LSI) is calculated based on the first 3 questions. The LSI scores can be used to classify respondents into active (LSI > 24) and insufficiently active (LSI < 23) categories.
Measured: Up to 52 weeks
Patient-Reported Outcomes
Assessed using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE [CTCAE Version 5.0]). PRO-CTCAE assesses 78 adverse events by self-report with 124 items. Each item uses a plain language term for the adverse event, the attribute of interest, and the standard recall period of "the past 7 days".
Measured: Up to 52 weeks
National Cancer Institute-Common Terminology Criteria for Adverse Events
The NCI-CTCAE is a subjective method to evaluate CIPN performed by a healthcare professional. The treating physician will grade the subject's dysesthesia, paresthesia, neuralgia, peripheral sensory neuropathy, and peripheral motor neuropathy on a scale of 0 to 5 depending on the severity. The advantage of the NCI-CTCAE is that the assessment is quick and easy for providers to perform, (8) but it is limited by the subjectivity of interpretation, lack of detail about location, type, and severity of impairment, and narrow scoring range.
Participants will only be graded for the event types listed above, so these will only be reported as an outcome measure, and will not appear in the adverse events section of this report.
Measured: Up to 52 weeks
Assess Incidence of CIPN
Assessed using European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 (CIPN-20). The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start14 May 2019
- Primary completion8 Apr 2025
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Meghna S Trivedi, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939481
- Sponsor's protocol ID
- S1714
- Other IDs
- NCI-2018-01568, S1714, SWOG-S1714, S1714, UG1CA189974
- Status last verified
- Sep 2026
- First submitted
- 1 May 2019
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes