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New drug combo aims to boost Radiation's punch against head and neck cancer

NCT ID NCT01783587

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety of adding the drug afatinib to standard radiation therapy for people with head and neck cancer at risk of recurrence. Afatinib blocks proteins that help cancer grow and may make cancer cells more sensitive to radiation. The study included 29 participants and aimed to find the safest dose of afatinib when given with radiation, with or without chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

29 people

The number who actually took part.

Started

Feb 2013

Finished

Jun 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically proven diagnosis of squamous cell carcinoma of the head and neck * Pathology from the primary surgery must be reviewed and finalized at either the Dana-Farber Cancer Institute/Brigham \& Women's Hospital or the pathology department at any participating institution * Status post gross total resection with curative intent * Primary tumor site: oral cavity, oropharynx, larynx, hypopharynx * Disease must be defined as either high-risk or intermediate risk * Definition of high-risk: Any of the following high-risk features: positive margins (defined as tumor at ink), extracapsular extension of lymph node, gross T4a or T4b primary tumor, any lymph node ≥ 6cm (N3) * Definition of intermediate-risk: Absence of any high-risk features AND any one of the following intermediate risk features: Two or more positive lymph nodes involved with squamous cell carcinoma, single lymph node \>3cm and \<6cm, perineural invasion, lymphovascular invasion, Level IV or level V involvement of oral cavity or oropharyngeal tumors, or T2 oral cavity tumor with \>5mm depth of invasion Exclusion Criteria: * Prior anti-epidermal growth factor (EGF) or anti-Human Epidermal Growth Factor Receptor-2 (HER2) therapy * Prior radiation therapy to the head and neck * Pregnant or breastfeeding * Distant metastases * Receiving other study agents * History of interstitial lung disease * Symptomatic peripheral neuropathy * Active or prior malignancy except non-melanoma skin cancer * History of allergic reactions attributed to compounds of similar chemical or biologic composition to afatinib or docetaxel * Cardiac left ventricular dysfunction * Uncontrolled intercurrent illness * HIV positive on combination antiretroviral therapy

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of the head and neck

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115, United States

  • Mount Sinai Medical Center/Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.