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Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7Phase 2NCT00408694

Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

A Phase 2 study testing 3-Dimensional Conformal Radiation Therapy, Bevacizumab and Cisplatin in people with Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, run by National Cancer Institute (NCI) at 108 sites in 2 countries.

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

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Dimensional Conformal Radiation Therapy, Bevacizumab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
108 sitesin 2 countries
Study dates
13 Dec 2006to 15 Dec 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

Who may be able to join

  • Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes
  • Histologic WHO types I-IIb/III
  • Stage IIB-IVB disease
  • No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
  • No distant metastases
  • Zubrod performance status 0-1
Show all 59Show fewer
  • WBC ? 4,000/mm?
  • Hemoglobin ? 9.0 g/dL
  • Platelet count ? 100,000/mm?
  • Absolute neutrophil count ? 1,500/mm?
  • INR ? 1.5
  • aPTT ? 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ? 1.5 times ULN
  • ALT and AST ? 1.5 times ULN
  • Bilirubin ? 1.5 times ULN
  • Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
  • Urine protein:creatinine (UPC) ratio < 1.0
  • If UPC > 0.5, 24-hour urine protein must be < 1,000 mg
  • Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
  • Conductive hearing loss from tumor-related otitis media is allowed
  • No severe, active comorbidity, including any of the following:
  • Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the past 6 months
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within the past 6 months
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
  • Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the past 12 months
  • Major medical or psychiatric illness that, in the opinion of the study investigator, would preclude study compliance
  • Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • History of significant weight loss (> 15% from baseline)
  • History of arterial thromboembolic events
  • Acquired immune deficiency syndrome
  • Transmural myocardial infarction
  • Cerebrovascular accident
  • Transient ischemic attack
  • Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance
  • No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • Nutritional and physical condition considered suitable for study treatment
  • No significant traumatic injury within the past 4 weeks
  • No history of allergic reaction to the study drugs
  • No baseline blood pressure > 150/100 mm Hg
  • No peripheral neuropathy ? grade 2
  • Not pregnant or nursing
  • Negative serum pregnancy test
  • Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
  • At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
  • No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
  • More than 15 days since prior biopsies
  • More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
  • More than 4 weeks since prior major surgical procedures
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior bevacizumab or other vascular endothelial growth factor-targeting agents
  • No prior systemic chemotherapy for the study cancer
  • Prior chemotherapy for a different cancer allowed
  • No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
  • No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
  • No concurrent prophylactic amifostine or pilocarpine
  • No other concurrent experimental therapeutic cancer treatments

Who cannot join

None listed.

Trial locations and contacts

108 sites in 2 countries.

108 sites in 2 countries

United States104 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • UPMC Cancer Center at Clarion Hospital

    Clarion, Pennsylvania, 16214

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network-Southside Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network-Florida Cancer Center Beaches

    Jacksonville Beach, Florida, 32250

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Upper Delaware Valley Cancer Center

    Milford, Pennsylvania, 18337

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • UPMC-Coraopolis/Heritage Valley Radiation Oncology

    Moon Township, Pennsylvania, 15108

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Mercy Health Partners-Hackley Campus

    Muskegon, Michigan, 49442

  • UPMC Cancer Center-Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • UPMC Jameson

    New Castle, Pennsylvania, 16105

  • Beth Israel Medical Center

    New York, New York, 10003

  • Saint Luke's Roosevelt Hospital Center - Saint Luke's Division

    New York, New York, 10025

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC Jefferson Regional Radiation Oncology

    Pittsburgh, Pennsylvania, 15236

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Mercy General Hospital Radiation Oncology Center

    Sacramento, California, 95819

  • Integrated Community Oncology Network-Flager Cancer Center

    Saint Augustine, Florida, 32086

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Children's Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UPMC Uniontown Hospital Radiation Oncology

    Uniontown, Pennsylvania, 15401

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Aspirus UW Cancer Center

    Wisconsin Rapids, Wisconsin, 54494

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil, and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.

SECONDARY OBJECTIVES:

  1. Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen.

II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen.

III. Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Being tested
3-Dimensional Conformal Radiation Therapy, Bevacizumab, Cisplatin, Fluorouracil, Intensity-Modulated Radiation Therapy

What participants receive

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

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT

    Undergo 3D-CRT

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • FluorouracilDrug

    Also called 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

Study groups in NCT00408694
Study groupRoleWhat they receive
Treatment (bevacizumab, cisplatin, fluorouracil, IMRT, 3D-CRT)ExperimentalBEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Biological: Bevacizumab; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Intensity-Modulated Radiation Therapy

What is being measured

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

  1. Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.

    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: From start of treatment to one year.

Secondary outcomes (8)

  1. Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.

    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.

  2. Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen

    Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.

    Measured: From start of treatment to end of treatment (approximately day 109).

  3. Death During or Within 30 Days of Discontinuation of Protocol Treatment.

    The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.

    Measured: From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).

  4. One- and Two-year Distant Metastases-free Rates

    Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.

    Measured: From registration to two years

  5. One- and Two-year Loco-regional Progression-free Rates

    Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.

    Measured: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

  6. One- and Two-year Progression-free Survival Rates

    Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases.

    Measured: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

  7. One- and Two-year Overall Survival Rates

    Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.

    Measured: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

  8. Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment

    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years.

Timeline

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

  1. First posted7 Dec 2006 (estimated)
  2. Study start13 Dec 2006
  3. Primary completion15 Dec 2011
  4. Study completion15 Dec 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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408694
Sponsor's protocol ID
NCI-2009-00736
Other IDs
NCI-2009-00736, RTOG-0615, CDR0000518526, RTOG 0615, RTOG-0615, U10CA021661
Status last verified
Jan 2018
First submitted
6 Dec 2006
Last updated
30 Jan 2018

Publications

  • Lee NY, Harris J, Kim J, Garden A, Mechalakos J, Pfister DG, Chan ATC, Hu K, Colevas AD, Frank S, Shenouda G, Bar-Ad V, Waldron JN, Harari PM, Raben A, Torres-Saavedra P, Le QT. Long-term Outcomes of Bevacizumab and Chemoradiation for Locoregionally Advanced Nasopharyngeal Carcinoma: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316094. doi: 10.1001/jamanetworkopen.2023.16094.

    PubMed 37266942

  • Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.

    PubMed 22178121

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3-Dimensional Conformal Radiation Therapy, Bevacizumab and Cisplatin in people with Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, run by National Cancer Institute (NCI) at 108 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 59 inclusion and 0 exclusion criteria. 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Canada. 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 18 Apr 2013). 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?

Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. (time frame: From start of treatment to one year.). 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 NCT00408694, 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 30 Jan 2018.

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