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Recurrent Head and Neck CarcinomaPhase 1NCT02474368

Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck

A Phase 1 study testing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Stereotactic Body Radiotherapy (SBRT) in people with Recurrent Head and Neck Carcinoma and Head and Neck Cancer Metastatic, run by Dana-Farber Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Stereotactic Body Radiotherapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Nov 2015to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • All cohorts:
  • Participants must have a pathologic cancer diagnosis.
  • No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix.
  • Only patients 18 years and older are eligible. There is no upper age limit but the patients must be able to medically tolerate the regimen. Adverse event data are currently unavailable on the use of SBRT for participants < 18 years of age, and thus children are excluded from this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix A).
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  • Ability to understand and the willingness to sign a written informed consent document
  • Cohort 1 (reirradiation in patients with head and neck cancers with gross unresectable disease):
  • History of radiation to the head and neck area (defined as above the clavicles) greater than 6 months previous
  • Pathologically proven recurrent disease or a second primary (squamous cell carcinoma of the head and neck, nasopharyngeal cancer, salivary gland cancer, or thyroid cancer) within the head and neck region, deemed to be unresectable or resected with gross residual disease remaining (determined by either operative/pathology report or post-surgical imaging)
  • Participants must have normal organ and marrow function as defined below:
  • Leukocytes ≥ 3,000/mcL (microliter)
  • Absolute neutrophil count > ↓1,500/mcL (microliter)
  • Platelets ≥100,000/mcL (microliter)
  • Total bilirubin within normal institutional limits
  • aspartate aminotransferase (AST (SGOT))/alanine aminotransferase (ALT (SGPT)) ≤ 2.5 x institutional upper limit of normal
  • Creatinine < 2 x upper limit of normal (ULN) or creatinine clearance ≥45 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  • Cohort 2 (patients with metastatic disease with targetable lesions within the head and neck):
  • Pathologically proven solid tumor (lymphomas excluded) with evidence of metastatic disease (including nodal disease)
  • Measurable disease within the head and neck region, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm and < 60 mm with neck CT scan. See section 10 for the evaluation of measurable disease.

Who cannot join

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • SBRT target size > 6 cm in maximum diameter (or greater than 100 cc in volume).
  • Participants may not be receiving any other study agents.
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with SBRT, breastfeeding should be discontinued if the mother is treated with SBRT.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skin.
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  • HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for interaction between conventional radiotherapy, SBRT and antiretroviral medications. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • Patients who are planned to receive the following medications:
  • Granulocyte stimulating factor (G-CSF)
  • Bevacizumab
  • Cyclosporine
  • Anti-tumor necrosis factor agents
  • Amifostine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Phase I Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck

This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.

Read the detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

Stereotactic body radiation was developed as imaging and treatment capabilities on radiation treatment machines became more accurate and more precise. Like standard radiation therapy, stereotactic body radiation kills tumor cells by causing small breaks in the DNA of these cells. In this research study, the investigators are looking for the highest dose of the stereotactic radiation that can be given safely either alone, or as a 'boost dose' in combination with standard radiation and chemotherapy. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects; the goal is to improve the likelihood of killing the tumor and, in some cases, to complete the course of radiation in a shorter amount of time.

Being tested
Intensity Modulated Radiation Therapy (IMRT), Cisplatin, Stereotactic Body Radiotherapy (SBRT)
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity Modulated Radiation Therapy (IMRT)Radiation

  • CisplatinDrug

    Also called Platinol-AQ, Platinol

  • Stereotactic Body Radiotherapy (SBRT)Radiation

Study groups in NCT02474368
Study groupRoleWhat they receive
Cohort 1Experimental* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 1 (patients who have received prior radiation in the head and neck with gross unresectable disease) * Intensity Modulated Radiation Therapy (IMRT) : daily for 6 weeks * Cisplatin will be administered intravenously on predetermined days * Stereotactic Body Radiotherapy (SBRT)
Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin; Radiation: Stereotactic Body Radiotherapy (SBRT)
Cohort 2Experimental* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 2 (patients with metastatic solid tumors of any histology who have targetable lesions within the head and neck) -- Stereotactic Body Radiotherapy (SBRT)
Receives: Radiation: Stereotactic Body Radiotherapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT)

    Cohort 1: patients who have received prior radiation in the head and neck and currently have gross unresectable disease;

    Measured: 1 Year

  2. Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given for disease metastatic to the head and neck

    Cohort 2: Patients with metastatic disease with targetable lesions within the head and neck.

    Measured: 1 year

Secondary outcomes (7)

  1. Number of Participants with Adverse Events

    Adverse events observed will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute, Common Toxicity Criteria for Adverse Effects - CTCAE v4 and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.

    Measured: 1 Year

  2. Local Control Rate

    Computed tomography (CT) and Positron emission tomography (PET) will be used to assess disease control within the field receiving radiation.

    Measured: 1 Year

  3. Regional Control Rate

    Computed tomography (CT) and Positron emission tomography (PET) will be used to assess disease control within the head and neck region.

    Measured: 1 Year

  4. Progression Free Survival using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Progression free survival will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. The median progression free survival time will be estimated using standard life table methods.

    Measured: 1 year

  5. Level of circulating activated T cells as an immune correlate of stereotactic treatment

    This will evaluate circulating immune cells before and after treatment and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.

    Measured: 1 Year

  6. Patient reported physical function before and after treatment

    This will investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire (UW-QOL v4) composite score for physical function and comparing results obtained before and after treatment.

    Measured: 1 year

  7. Patient reported social function before and after treatment

    This will investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire (UW-QOL v4) composite score for social function and comparing results obtained before and after treatment.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJan 2021
  4. Study completionJun 2027 (estimated)

Resources

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02474368
Sponsor's protocol ID
15-183
Status last verified
Jul 2026
First submitted
13 Jun 2015
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Stereotactic Body Radiotherapy (SBRT) in people with Recurrent Head and Neck Carcinoma and Head and Neck Cancer Metastatic, run by Dana-Farber Cancer Institute at 1 site 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 20 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT) (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02474368.

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 14 Jul 2026.

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