Fewer radiation sessions may be safe for head and neck cancer patients
NCT ID NCT05120947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving fewer, higher-dose radiation sessions after surgery for head and neck cancer is safe. Eighteen adults with certain risk factors received one of three shortened radiation schedules. The goal was to find the shortest course that does not cause severe side effects within a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (hypofractionated)
- What this could lead to
- If successful, this could lead to shorter, more convenient radiation treatment after surgery for head and neck cancer, reducing the number of hospital visits.
- What could go wrong
- This is a very small, early-phase study with only 18 participants, so results may not apply to everyone. Higher radiation doses per session could increase side effects.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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18 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Patients 18 years or older with gross totally resected (R0 resection) Human papillomavirus (HPV) -negative squamous cell carcinoma of the head and neck (squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, nasal cavity, paranasal sinuses or carcinoma of unknown head/neck primary) who have at least 1 of the following intermediate risk factors for adjuvant radiation: 1. Pathologic Node Positive Disease 2. Perineural Invasion 3. Oral cavity cancer with depth of invasion of at least 5 mm 4. Lymphovascular Space Invasion 5. Pathologic T3 or T4 disease 2. Zubrod performance status 0-2. 3. Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up. 4. Inclusion of Covid-19 positive patients will be based on standard institutional protocol. 5. Female patients must meet one of the following: * Postmenopausal for at least one year before the screening visit, or * Surgically sterile (i.e. undergone a hysterectomy or bilateral oophorectomy), or * If subject is of childbearing potential (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, AND o Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptom-thermal, post ovulation methods\] and withdrawal are not acceptable contraception methods). 6. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: * Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR * Must also adhere to the guidelines of any study-specific pregnancy prevention program, if applicable, OR o Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptom-thermal, post ovulation methods\] and withdrawal are not acceptable methods of contraception.) 7. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Pathologic evidence of extranodal extension. 2. Pathologic evidence of a final positive margin (R1 resection) or gross residual disease (R2 resection). 3. HPV-positive squamous cell carcinoma. 4. Prior invasive malignancy within the past 3 years (except for non-melanomatous skin cancer, and early stage treated prostate cancer). 5. Life expectancy less than 12 months. 6. Performance status Zubrod ≥ 3. 7. Patients with prior radiation therapy to the head and neck Note: Prior external beam radiotherapy is excluded, but Iodine 131 is allowed. 8. Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy, or immune therapy for the study cancer. 9. Body weight ≤ 30 kg. 10. Any of the following severe laboratory abnormalities within 14 days of registration, unless corrected prior to it: Sodium \< 130 mmol/L or \> 155 mmol/L; Potassium \< 3.5 mmol/L or \> 6 mmol/L; Fasting glucose \< 40 mg/dl or \> 400 mg/dl; Serum calcium (ionized or adjusted for albumin) \< 7 mg/dl or \> 12.5 mg/dl; Magnesium \< 0.9 mg/dl or \> 3 mg/dl. 11. Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to Step 1 registration. 12. Transmural myocardial infarction within three months prior to Step 1 registration. 13. Medical or psychiatric illness which would compromise the patient's ability to tolerate treatment or limit compliance with study requirements. 14. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 6 months after radiation, this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding are also excluded.
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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
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Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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