AzTrials
AzTrials

Esophageal CancerPhase 2NCT00086996

S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

A Phase 2 study testing fluorouracil, oxaliplatin and conventional surgery in people with Esophageal Cancer, run by SWOG Cancer Research Network at 143 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 fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
fluorouracil, oxaliplatin and conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
143 sitesUnited States
Study dates
Sep 2004to Aug 2011
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:

  • Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction
  • No recurrent disease
  • Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
  • Esophageal disease confined to esophagus and peri-esophageal soft tissue
  • Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia
  • Clinical stage II or III disease by CT scan or MRI
  • If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
  • Positron-emission tomography scan is required to confirm stage
  • Measurable or non-measurable disease by x-ray, scanning, or physical examination
  • No celiac axis nodes ≥ 1.5 cm
  • Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
  • Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • White blood cell (WBC) count ≥ 3,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

  • Albumin ≥ 3 g/dL
  • Bilirubin normal

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

  • No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

  • No active pneumonia or inflammatory lung infiltrate

Other

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for esophageal cancer
  • No concurrent intensity-modulated radiotherapy

Surgery

  • No prior surgical resection or attempted surgical resection of esophageal cancer

Trial locations and contacts

143 sites in 1 country.

143 sites in 1 country

United States143 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • 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

  • Highlands Oncology Group - Springdale

    Bentonville, Arkansas, 72712

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • 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

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • 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

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Valley Medical Oncology

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • 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

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Frontier Cancer Center

    Great Falls, Montana, 59405

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

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

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • 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

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southwest Medical Center

    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

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

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

    Ogden, Utah, 84403

  • Olathe Cancer Center

    Olathe, Kansas, 66061

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants - Pleasanton

    Pleasanton, California, 94588

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • LDS Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • 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, 98195-6043

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • 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

  • Rockwood Clinic Cancer Treatment Center

    Spokane, Washington, 99204-2967

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • 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

  • 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

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • 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: Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.

Secondary

  • Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.

Exploratory Analyses (subject to funding availability)

  • Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine (γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum (XPA) with response and survival of patients treated with this regimen.
  • Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and after treatment with this regimen with survival of these patients.
  • Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.
  • Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy.
  • Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.

Being tested
fluorouracil, oxaliplatin, conventional surgery, radiation therapy
Keywords
adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

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

  • fluorouracilDrug

    Also called 5-FU

    Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.

  • oxaliplatinDrug

    Also called eloxatin

    Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.

  • conventional surgeryProcedure or surgery

    The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.

  • radiation therapyRadiation

    Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.

Study groups in NCT00086996
Study groupRoleWhat they receive
Chemo Plus RT, Surgery, ChemoExperimentalneoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
Receives: Drug: fluorouracil; Drug: oxaliplatin; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

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

  1. Pathological Complete Response

    Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.

    Measured: 10-16 weeks after beginning study treatment

Secondary outcomes (3)

  1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

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

    Measured: Up to 3 years

  2. Overall Survival

    Measured from time of registration to death, or last contact date

    Measured: 0-5 years

  3. Progression-free Survival

    measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.

    Measured: 0-3 years

Timeline

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

  1. First posted12 Jul 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2009
  4. Study completionAug 2011

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
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086996
Sponsor's protocol ID
CDR0000371963
Other IDs
U10CA032102, S0356
Status last verified
Sep 2013
First submitted
8 Jul 2004
Last updated
11 Oct 2013
Data monitoring committee
Yes

Publications

  • Leichman L, Goldman BH, Benedetti JK, et al.: Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356). [Abstract] J Clin Oncol 27 (Suppl 15): A-4513, 2009.

  • Leichman LP, Goldman BH, Bohanes PO, Lenz HJ, Thomas CR, Billingsley KG, Corless CL, Iqbal S, Gold PJ, Benedetti JK, Danenberg KD, Blanke CD. S0356: a phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and external-beam radiation therapy before surgery for patients with esophageal adenocarcinoma. J Clin Oncol. 2011 Dec 1;29(34):4555-60. doi: 10.1200/JCO.2011.36.7490. Epub 2011 Oct 24.

    PubMed 22025151

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, oxaliplatin and conventional surgery in people with Esophageal Cancer, run by SWOG Cancer Research Network at 143 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 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 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 3 Apr 2012). 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?

Pathological Complete Response (time frame: 10-16 weeks after beginning study treatment). 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 NCT00086996, which also lists 2 linked publications.

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 11 Oct 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in