NCT01711658

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 human papillomavirus (HPV).

Conditions

• Non-HPV Locally Advanced Head and Neck Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-15
• Primary completion: 2020-12-01
• Completion: 2022-09-21
• First posted: 2012-10-22
• Last updated: 2023-10-17
• Results posted: 2021-11-29

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study