Squamous Cell Carcinoma of the Head and NeckPhase 1NCT01783587
Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer
A Phase 1 study testing Afatinib, Docetaxel and Radiation Therapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Afatinib, Docetaxel and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to 1 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mount Sinai Medical Center/Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Phase I Study of Afatinib With Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause.
Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy.
Read more
The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer.
Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy.
The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.
Read the detailed description
If you are willing to take part in this study you will be asked to undergo some screening tests and procedures to confirm your eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if you do not take part in the research study. If you already had some of these tests and procedures recently, they may or may not have to be repeated. The tests and procedures include: a review of your medical history, physical exam, blood samples, urine sample, serum pregnancy test, electrocardiogram, echocardiogram and an assessment of your disease to find out the extent of your cancer. If these tests show that you are eligible to participate in the research study, you may begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
We will collect an archive tumor specimen (leftover tissue from your prior surgery or biopsies) to confirm your cancer diagnosis. Additional tests on the tumor specimen may be performed as a part of future studies to gain new knowledge about head and neck cancer.
You will receive Afatinib as a pill that you take by mouth for 7 weeks. During the first week, you will receive Afatinib alone. During the second through seventh weeks, you will receive Afatinib together with Radiation Therapy OR with Docetaxel and Radiation Therapy. Docetaxel is given intravenously, once a week during Week 2 through Week 7. Not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they tolerated their doses.
Afatinib needs to be taken on an empty stomach. Specific instructions about this will be included in the drug diary you will need to complete.
If you take part in this research study, you will receive the same radiation that you would receive if you were not on the study. The radiation is typically done daily Monday through Friday for about 6-7 weeks. You will sign a separate consent form with your radiation oncologist that will outline what to expect with this treatment.
You will be given a physical exam every week during your treatment. You will have a physical exam and be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
You will have blood tests every week during your treatment including chemistry and hematology tests and a pregnancy test if you are a woman capable of becoming pregnant before you receive your first infusion of docetaxel.
You will also be asked to return to the clinic one week, four weeks and eight weeks after finishing your treatment. Most of these visits are part of routine visits after finishing treatment. If you stop the study early for any reason, you will also have a clinic visit. In either instance, the following exams and procedures will be performed: physical exam, blood tests, other tests including an electrocardiogram, MUGA scan or echocardiogram, CT scan and a PET/CT scan.
- Being tested
- Afatinib, Docetaxel, Radiation Therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Also called Gilotrif
Taken orally once per day
DocetaxelDrug
Also called Taxotere
15 mg/m2, given intravenously once per week
Radiation TherapyRadiation
Daily, Monday-Friday, for six to seven weeks
| Study group | Role | What they receive |
|---|---|---|
| High Risk Group | Experimental | Dose escalation of afatinib + docetaxel + radiation therapy Receives: Drug: Afatinib; Drug: Docetaxel; Radiation: Radiation Therapy |
| Intermediate Risk Group | Experimental | Dose escalation of afatinib + radiation therapy Receives: Drug: Afatinib; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of a dose-limiting toxicity at a given dose-level of afatinib.
All participants who receive any amount of study drug will be evaluable for toxicity. The primary outcome measure is the incidence of a physician-assessed dose-limiting toxicity (DLT) at a given dose-level of afatinib. Participants will be assessed for a DLT at least once per week during the course of therapy, including the one-week afatinib lead-in period and the 6-7 weeks of radiation therapy. DLT's are defined as the incidence of a severe or life-threatening toxicity (grade 3-4) as defined by the Common Terminology Criteria for Adverse Events Versions 4 (CTCAEv.4) or any afatinib-related toxicity requiring a dose reduction occurring during treatment with afatinib and radiation therapy +/- docetaxel. Participants will continue to be assessed for adverse events for 12 weeks after the completion of therapy.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion20 Nov 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Danielle Margalit, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Danielle Margalit, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783587
- Sponsor's protocol ID
- 12-267
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2013
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Afatinib With Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT01783587
- Acronym / sponsor ID
- 12-267
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Feb 2013 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause.
Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy.
The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer.
Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy.
The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.
Detailed description
If you are willing to take part in this study you will be asked to undergo some screening tests and procedures to confirm your eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if you do not take part in the research study. If you already had some of these tests and procedures recently, they may or may not have to be repeated. The tests and procedures include: a review of your medical history, physical exam, blood samples, urine sample, serum pregnancy test, electrocardiogram, echocardiogram and an assessment of your disease to find out the extent of your cancer. If these tests show that you are eligible to participate in the research study, you may begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
We will collect an archive tumor specimen (leftover tissue from your prior surgery or biopsies) to confirm your cancer diagnosis. Additional tests on the tumor specimen may be performed as a part of future studies to gain new knowledge about head and neck cancer.
You will receive Afatinib as a pill that you take by mouth for 7 weeks. During the first week, you will receive Afatinib alone. During the second through seventh weeks, you will receive Afatinib together with Radiation Therapy OR with Docetaxel and Radiation Therapy. Docetaxel is given intravenously, once a week during Week 2 through Week 7. Not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they tolerated their doses.
Afatinib needs to be taken on an empty stomach. Specific instructions about this will be included in the drug diary you will need to complete.
If you take part in this research study, you will receive the same radiation that you would receive if you were not on the study. The radiation is typically done daily Monday through Friday for about 6-7 weeks. You will sign a separate consent form with your radiation oncologist that will outline what to expect with this treatment.
You will be given a physical exam every week during your treatment. You will have a physical exam and be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
You will have blood tests every week during your treatment including chemistry and hematology tests and a pregnancy test if you are a woman capable of becoming pregnant before you receive your first infusion of docetaxel.
You will also be asked to return to the clinic one week, four weeks and eight weeks after finishing your treatment. Most of these visits are part of routine visits after finishing treatment. If you stop the study early for any reason, you will also have a clinic visit. In either instance, the following exams and procedures will be performed: physical exam, blood tests, other tests including an electrocardiogram, MUGA scan or echocardiogram, CT scan and a PET/CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Group | Experimental | Drug: Afatinib, Drug: Docetaxel, Radiation: Radiation TherapyDose escalation of afatinib + docetaxel + radiation therapy |
| Intermediate Risk Group | Experimental | Drug: Afatinib, Radiation: Radiation TherapyDose escalation of afatinib + radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfatinibAlso: GilotrifTaken orally once per day | Drug | High Risk Group, Intermediate Risk Group |
| DocetaxelAlso: Taxotere15 mg/m2, given intravenously once per week | Drug | High Risk Group |
| Radiation TherapyDaily, Monday-Friday, for six to seven weeks | Radiation | High Risk Group, Intermediate Risk Group |
Primary outcome
The presence or absence of a dose-limiting toxicity at a given dose-level of afatinib.
Time frame: 7 weeks
All participants who receive any amount of study drug will be evaluable for toxicity. The primary outcome measure is the incidence of a physician-assessed dose-limiting toxicity (DLT) at a given dose-level of afatinib. Participants will be assessed for a DLT at least once per week during the course of therapy, including the one-week afatinib lead-in period and the 6-7 weeks of radiation therapy. DLT's are defined as the incidence of a severe or life-threatening toxicity (grade 3-4) as defined by the Common Terminology Criteria for Adverse Events Versions 4 (CTCAEv.4) or any afatinib-related toxicity requiring a dose reduction occurring during treatment with afatinib and radiation therapy +/- docetaxel. Participants will continue to be assessed for adverse events for 12 weeks after the completion of therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Margalit, MD, MPH principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib, Docetaxel and Radiation Therapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence or absence of a dose-limiting toxicity at a given dose-level of afatinib. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.