TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

March 15, 2013

Primary Completion Date

December 1, 2020

Study Completion Date

September 21, 2022

Conditions
Non-HPV Locally Advanced Head and Neck Cancer
Interventions
RADIATION

IMRT

Intensity modulated radiation therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy

DRUG

Cisplatin

100 mg/m\^2 administered intravenously on days 8 and 29

DRUG

placebo

1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT

DRUG

Lapatinib

1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT

Trial Locations (16)

18925

Fox Chase Cancer Center Buckingham, Furlong

30308

Emory University, Atlanta

35294

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham

40202

James Graham Brown Cancer Center at University of Louisville, Louisville

43210

Ohio State University Medical Center, Columbus

44106

University Hospitals of Cleveland, Cleveland

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Comprehensive Cancer Center, Madison

73190

University of Oklahoma Health Sciences Center, Oklahoma City

75390

University of Texas Southwestern Medical School, Dallas

92093

University of California, San Diego, La Jolla

94143

University of California San Francisco, San Francisco

95816

Sutter General Hospital, Sacramento

06520

Yale University, New Haven

77030-4009

University of Texas - MD Anderson Cancer Center, Houston

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Radiation Therapy Oncology Group

NETWORK

NCT01711658 - TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. | Biotech Hunter | Biotech Hunter