AzTrials
AzTrials

Colorectal CancerPhase 2NCT00686166

S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

A Phase 2 study testing cetuximab, capecitabine and oxaliplatin in people with Colorectal Cancer, run by SWOG Cancer Research Network at 130 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
cetuximab, capecitabine and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
130 sitesUnited States
Study dates
Feb 2009to Mar 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

DISEASE CHARACTERISTICS:

  • Biopsy-proven primary adenocarcinoma of the rectum
  • Stage II or III disease
  • The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination
  • No recurrent disease
  • Must have wild-type k-ras status
  • Measurable and/or nonmeasurable disease

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Leukocyte count ≥ 3,000/mcL
  • Granulocyte count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN
  • Creatinine clearance > 50 mL/min
  • No prior severe reaction to a monoclonal antibody
  • Willing to have specimens submitted
  • No peripheral neuropathy ≥ grade 2
  • No known existing uncontrolled coagulopathy
  • No evidence of current high-grade obstruction
  • At least 2 weeks since prior diverting procedure
  • No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment
  • No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency
  • No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine
  • No uncontrolled intercurrent illness
  • No ongoing or active infection
  • No symptomatic congestive heart failure or unstable angina pectoris
  • No cardiac arrhythmia or myocardial infarction within the past 12 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery)
  • No prior chemotherapy, radiotherapy, or targeted therapy for this tumor
  • More than 4 weeks since prior investigational agents
  • No concurrent anti-retroviral therapy for HIV

Trial locations and contacts

130 sites in 1 country.

130 sites in 1 country

United States130 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • American Fork Hospital

    American Fork, Utah, 84003

  • Island Hospital Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Southwest Regional Cancer Center - Central

    Austin, Texas, 78705

  • Texas Oncology, PA at Texas Oncology Cancer Center - Central

    Austin, Texas, 78731

  • Texas Oncology, PA at South Austin Cancer Center

    Austin, Texas, 78745

  • Texas Oncology, PA - Austin North

    Austin, Texas, 78758

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Highline Medical Center Cancer Center

    Burien, Washington, 98166

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Texas Oncology, PA - Cedar Park

    Cedar Park, Texas, 78613

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Hays Medical Center

    Hays, Kansas, 67601

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • Hutchinson Hospital Corporation

    Hutchinson, Kansas, 67502

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Swedish Medical Center - Issaquah Campus

    Issaquah, Washington, 98029

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Kansas City Cancer Centers - West

    Kansas City, Kansas, 66112

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • U.T. Medical Center Cancer Institute

    Knoxville, Tennessee, 37920-6999

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Kansas City Cancer Centers - East

    Lee's Summit, Missouri, 64064

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Logan Regional Hospital

    Logan, Utah, 84321

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98274

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Mercy General Health Partners

    Muskegon, Michigan, 49444

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Sutter Health - Western Division Cancer Research Group

    Novato, California, 94945

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Cancer Center at Roseville Medical Center

    Roseville, California, 95661

  • Texas Oncology, PA - Seton Williamson

    Round Rock, Texas, 78665

  • Texas Oncology, PA at Texas Cancer Center Round Rock

    Round Rock, Texas, 78681

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Texas Oncology, PA - San Marcos

    San Marcos, Texas, 78666

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Kansas City Cancer Center - Shawnee Mission

    Shawnee Mission, Kansas, 66204

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Arizona Cancer Center at UMC Orange Grove

    Tucson, Arizona, 85704

  • Arizona Cancer Center at University Medical Center North

    Tucson, Arizona, 85719

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.

Read the detailed description

OBJECTIVES:

  • To assess the pathologic complete response rate for the combination of oxaliplatin, capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras.
  • To estimate the 3-year disease-free survival probability in this patient population when treated with this regimen.
  • To assess the frequency and severity of toxicities associated with this regimen in these patients.
  • To explore, preliminarily, the association between expression levels of genes involved in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU pathway (i.e., k-ras, TS [Thymidylate Synthase], ERCC-1 [excision repair cross complementing-1), TP [Thymidine phosphorylase], DPD [Dihydropyrimidine dehydrogenase], EGFR, VEGF [vascular endothelial growth factor], and IL-8 [interleukin-8]) and pathologic complete response. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)
  • To explore, preliminarily, the intratumoral gene expression levels of these genes after completion of study treatment.(Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)
  • To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation with clinical outcome and toxicity. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a week for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and cetuximab IV over 1-2 hours once a week for 5 weeks.
  • Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later, patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5. Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo external beam radiotherapy 5 days a week for 5 weeks beginning in week 1.

Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 3-8 weeks after completion of chemoradiotherapy.

Blood samples are collected for germline polymorphism testing and tissue samples are collected and assessed for gene expression analysis.

After completion of study treatment, patients are followed every 6 months for 4 years.

Being tested
cetuximab, capecitabine, oxaliplatin, therapeutic surgical procedure, radiation therapy
Keywords
adenocarcinoma of the rectum, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    Also called IMG-C225, Erbitux, NSC-714692

    Chemotherapy cycle 1: Cetuximab, 400 mg/m^2, IV, Day 1; Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29

    Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78

  • capecitabineDrug

    Also called Xeloda, NSC-712807

    Chemotherapy Cycle 1: Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

    Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)

  • oxaliplatinDrug

    Also called Eloxatin, NSC-266046

    Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29

    Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78

  • therapeutic surgical procedureProcedure or surgery

    Also called Resection

    Surgical resection

  • radiation therapyRadiation

    Also called RT

    IMRT (intensity-modulated radiation therapy)

Study groups in NCT00686166
Study groupRoleWhat they receive
Chemo + Chemo and radiation + SurgeryExperimentalChemotherapy Cycle 1 (1 cycle is 35 days): * Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29 * Cetuximab, 400 mg/m^2, IV, Day 1 * Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29 * Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35) Chemotherapy+ Radiation Cycle 2: * Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78 * Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78 * Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84) * Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions. Therapeutic Surgical procedure: Resection
Receives: Biological: cetuximab; Drug: capecitabine; Drug: oxaliplatin; Procedure: therapeutic surgical procedure; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response Rate

    Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.

    Measured: 15-20 weeks from registration

Secondary outcomes (2)

  1. 3-year Disease-free Survival

    From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

    Measured: 3 years

  2. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.

    Only adverse events that are possibly, probably or definitely related to study regimen are reported.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2014
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686166
Sponsor's protocol ID
S0713
Other IDs
S0713, U10CA032102
Status last verified
Apr 2018
First submitted
28 May 2008
Last updated
18 May 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, capecitabine and oxaliplatin in people with Colorectal Cancer, run by SWOG Cancer Research Network at 130 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response Rate (time frame: 15-20 weeks from registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00686166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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