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Chemotherapy

IMRT + cisplatin + lapatinib for Locally Advanced Head and Neck Cancer (TRYHARD Trial)

Phase 2

Waitlist Available

Led By Stuart Wong, MD

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 7.1 years.

Awards & highlights

TRYHARD Trial Summary

This trial is studying the effectiveness of lapatinib when added to radiation therapy and cisplatin in patients with head and neck cancer.

Eligible Conditions

Non-HPV Locally Advanced Head and Neck Cancer

TRYHARD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 7.1 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 7.1 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 7.1 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Alive Without Progression (Progression-free Survival)

Secondary outcome measures

Functional Assessment of Cancer Therapy - Head & Neck.

HER2, EGFR, EMT as Biomarkers of Response.

Percentage of Participants Alive (Overall Survival)

+6 more

TRYHARD Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IMRT + cisplatin + lapatinibActive Control3 Interventions

IMRT with cisplatin and lapatinib

Group II: IMRT + cisplatin + placeboPlacebo Group3 Interventions

Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor

190 Previous Clinical Trials

64,785 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,310 Total Patients Enrolled

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,128 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01711658 — Phase 2

Locally Advanced Head and Neck Cancer Research Study Groups: IMRT + cisplatin + placebo, IMRT + cisplatin + lapatinib

Locally Advanced Head and Neck Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01711658 — Phase 2

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01711658 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the use of Radiation therapy (IMRT) + cisplatin + lapatinib an FDA approved treatment?

"Since this is a phase 2 trial, there is only some data supporting the safety of this radiation therapy. There are no known studies that support its efficacy."

Answered by AI

What type of cancer do doctors usually treat with the combination of Radiation therapy (IMRT) + cisplatin + lapatinib?

"While most commonly used to treat advanced testicular cancer, radiation therapy (IMRT) + cisplatin + lapatinib can also be an effective treatment for other conditions such as breast neoplasm metastasis and advanced ovarian cancer."

Answered by AI

Are there any other research papers that look at the effects of adding lapatinib to IMRT and cisplatin?

"3769 clinical trials have completed studying the effects of radiation therapy (IMRT) + cisplatin + lapatinib since it was first researched in 1997 at City of Hope Comprehensive Cancer Center. There are now 736 active studies, many of which originate from Furlong, Pennsylvania."

Answered by AI

At how many hospitals is this experiment being done?

"There are a total of 16 sites where this clinical trial is recruiting patients. Some notable locations include Furlong, San Francisco and Dallas; however, there are many other places where you may be able to participate. It would be best if you chose a location near you to limit travel time and costs."

Answered by AI

Is this research project enrolling new participants at this time?

"At this time, this particular study is no longer actively searching for participants. Although, it was first posted on 3/15/2013 and most recently updated on 10/29/2021. There are presently 408 clinical trials actively recruiting patients with malignant neoplasms and 736 studies for Radiation therapy (IMRT) + cisplatin + lapatinib that are enrolling patients."

Answered by AI

How many people are test subjects in this experiment?

"Currently, this clinical trial is not recruiting patients. However, there are 736 other trials for Radiation therapy (IMRT) + cisplatin + lapatinib that are actively searching for participants."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer

Ang, K. Kian, Jonathan Harris, Richard Wheeler, Randal Weber, David I. Rosenthal, Phuc Felix Nguyen-Tân, William H. Westra, et al.. 2010. “Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0912217.

New England Journal of MedicineJournal

Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer

clinicaltrials.govStudy

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

2013. "TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01711658.