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Trial record 1 of 1 for:    RTOG 3501
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TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. (TRYHARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Radiation Therapy Oncology Group
Sponsor:
Collaborators:
GlaxoSmithKline
NRG Oncology
Novartis
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01711658
First received: October 16, 2012
Last updated: December 30, 2016
Last verified: December 2016
  Purpose
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.

Condition Intervention Phase
Non-HPV Locally Advanced Head and Neck Cancer
Radiation: Intensity Modulated Radiation Therapy (IMRT)
Drug: Cisplatin
Drug: placebo
Drug: Lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Progression-Free survival [ Time Frame: 2 years ]
    The time from randomization until local, regional, or distant disease progression, or death.


Secondary Outcome Measures:
  • Distant metastasis [ Time Frame: 2 years ]
    The time from randomization until development of distant metastasis.

  • Adverse Events [ Time Frame: Participants are followed for up to 8 months from the start of treatment ]
    Data is collected during protocol treatment and 30 days after whether or not related to the study drug.

  • Compliance with planned treatment [ Time Frame: maintenance therapy is 3 months and could be different for each patient. ]
  • Local-regional failure [ Time Frame: 2 years ]
    The time from randomization until local-regional recurrence or progression.

  • Performance Status Scale for Head & Neck Cancer. [ Time Frame: 3 months, 1 year, and 2 years ]
  • Functional Assessment of Cancer Therapy - Head & Neck. [ Time Frame: 3 months, 1 year, and 2 years. ]
  • University of Michigan Xerostomia-Related Quality of Life Scale. [ Time Frame: 3 months, 1 year, and 2 years. ]
  • HER2, EGFR, EMT as biomarkers of response. [ Time Frame: End of Study ]
  • Overall Survival [ Time Frame: 2 years ]
    The time from randomization until death


Estimated Enrollment: 142
Study Start Date: November 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Radiation therapy (IMRT) + cisplatin + placebo
Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + placebo
Radiation: Intensity Modulated Radiation Therapy (IMRT)
70 Gy in 2 Gy fractions
Drug: Cisplatin
100 mg/m2 on days 8 and 29
Drug: placebo
1500 mg daily one week prior to radiation, followed by 1500 mg daily concurrent with radiation, followed by 1500 mg daily for 3 months
Active Comparator: Radiation therapy (IMRT) + cisplatin + lapatinib
Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + lapatinib
Radiation: Intensity Modulated Radiation Therapy (IMRT)
70 Gy in 2 Gy fractions
Drug: Cisplatin
100 mg/m2 on days 8 and 29
Drug: Lapatinib
1500 mg daily one week prior to radiation, followed by 1500 mg daily concurrent with radiation, followed by 1500 mg daily for 3 months

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
  • Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3p16 negative oropharynx cancer or T1-2 any N hypopharynx cancer) including no distant metastases.
  • History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
  • Examination by an ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to entering the study.
  • Patients must have a chest CT scan, or PET/CT scan to rule out metastatic disease
  • Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site and neck nodes prior to entering the study.
  • Patients must have an EKG and ECHO or MUGA scan prior to entering the study.
  • Patients must have Zubrod Performance Status of 0-1.
  • Patients must be ≥ 18 years of age.
  • Patients must have normal organ and marrow function as defined below:

    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 8.0 g/dl
    • Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
    • Total bilirubin < 2 x the institutional upper limit of normal
    • AST or ALT ≤ 3 x the institutional upper limit of normal
  • Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
  • Women of childbearing potential must have a negative pregnancy test prior to registration.
  • Patients of reproductive potential must practice effective contraception while on study and for at least 60 calendar days following treatment.
  • All patients must sign an informed consent prior to enrollment.
  • Patients must comply with the treatment plan and follow-up schedule.

Exclusion criteria:

  • Patients with simultaneous primaries or bilateral tumors.
  • Patients who have had gross total excision of the primary tumor.
  • Patients with initial surgical treatment, radical or modified neck dissection.
  • Patients who received prior systemic chemotherapy for the study cancer.
  • Patients who received prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
  • Prior allergic reaction to the study drugs.
  • Patients who have had prior therapy that specifically and directly targets the EGFR/HER2 pathway.
  • Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment);
  • Pregnant women or sexually active patients not willing or able to use medically acceptable forms of contraceptive method while on treatment.
  • Patients with severe, active co-morbidity, defined as follows:

    • Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Left ventricular ejection fraction < 45%
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 calendar days prior to registration
    • Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
    • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711658

Contacts
Contact: Stuart Wong, MD swong@mcw.edu

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - University of Alabama at Birmingham C    205-934-0309      
Principal Investigator: Jennifer De Los Santos, MD         
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Loren Mell, MD       lmell@ucsd.edu   
Principal Investigator: Loren Mell, MD         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Christopher Jones       jonescu@sutterhealth.org   
Principal Investigator: Christopher Jones, MD         
University of California San Francisco Active, not recruiting
San Francisco, California, United States, 94143
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Barbara Burtness, MD    203-737-7636      
Principal Investigator: Barbara Burtness, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: Jonathan J. Beitler    404-686-4411      
Principal Investigator: Jonathan Beitler, MD         
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Neal Dunlap, MD    502-561-2704      
Principal Investigator: Neal Dunlap, MD         
United States, North Carolina
Duke University Withdrawn
Durham, North Carolina, United States, 27710-7512
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Min Yao       min.yao@uhhospitals.org   
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Maura L Gillison, MD, PhD       maura.gillison@osumc.edu   
Principal Investigator: Maura Gillison, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73190
Contact: Terrance Herman, MD       terence-herman@ouhsc.edu   
Principal Investigator: Terrence Herman, MD         
United States, Pennsylvania
Fox Chase Cancer Center Buckingham Recruiting
Furlong, Pennsylvania, United States, 18925
Contact: Thomas Galloway, MD       thomas.galloway@fccc.edu   
Principal Investigator: Thomas Galloway, MD         
United States, Texas
University of Texas Southwestern Medical School Active, not recruiting
Dallas, Texas, United States, 75390
University of Texas - MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Paul M. Harari    608-263-8500      
Principal Investigator: Paul Harari, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Stuart Wong, MD       swong@mcw.edu   
Principal Investigator: Stuart Wong, MD         
Canada, Quebec
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: George Shenouda    514-398-1444      
Principal Investigator: George Shenouda, MD         
Sponsors and Collaborators
Radiation Therapy Oncology Group
GlaxoSmithKline
NRG Oncology
Novartis
Investigators
Principal Investigator: Stuart Wong, MD Medical College of Wisconsin
  More Information

Publications:
Harrington K. et al. Phase II study of oral Lapatinib, a dual-tyrosine kinase inhibitor, combined with chemoradiotherapy (CRT) in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). J Clin Oncol. 28:15s, 2010 suppl. Abstract 5505. GSK study 884

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01711658     History of Changes
Other Study ID Numbers: RF-3501
LAP116153 ( Other Identifier: GlaxoSmith Kline, LLC )
Study First Received: October 16, 2012
Last Updated: December 30, 2016

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Lapatinib
Cisplatin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2017