Sharper radiation boost aims to tackle head and neck cancers that return

NCT ID NCT02474368

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This phase 1 study tests whether adding a highly targeted, high-dose radiation boost (stereotactic body radiotherapy, or SBRT) to standard radiation and chemotherapy can safely treat head and neck cancer that has come back or spread. The trial includes two groups: patients whose cancer has returned after prior radiation, and those with new tumors in the head and neck from cancer that started elsewhere. The main goal is to find the highest safe dose of the SBRT boost.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of stereotactic body radiotherapy (SBRT), intensity modulated radiation therapy (IMRT), and cisplatin chemotherapy
What this could lead to
If successful, this approach could offer a new treatment option for patients with head and neck cancer that has returned or spread.
What could go wrong
This is an early phase 1 trial with a small number of participants, so the safety and effectiveness are not yet established. The high-dose radiation may cause significant side effects.

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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

21 people

The number who actually took part.

Start date

Nov 2015

Expected to finish

Jun 2027

An estimate. End dates often move.

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: * 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). * 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. Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

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