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

Conditions

• Non-HPV Locally Advanced Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IMRT — RADIATION
  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
• Cisplatin — DRUG
  100 mg/m\^2 administered intravenously on days 8 and 29
• placebo — DRUG
  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
• Lapatinib — DRUG
  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

Study Details

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).

Key Dates

Start date

Mar 15, 2013

Status verified

Oct 2021

Primary completion

Dec 1, 2020

Completion

Sep 21, 2022

Study Design

Enrollment

142 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: IMRT + cisplatin + placebo
  Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
• Active Comparator: IMRT + cisplatin + lapatinib
  IMRT with cisplatin and lapatinib

Primary Outcome Measure

Percentage of Participants Alive Without Progression (Progression-free Survival) [ Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. ]

Locations (15)

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