Can less be more? new trial aims to cut side effects in HPV throat cancer
NCT ID NCT03621696
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving less intense treatment after surgery for HPV-related throat cancer can reduce side effects like weight loss and the need for a feeding tube. 63 patients had surgery and then received either lower-dose radiation or no radiation, depending on their risk level. The goal was to keep the cancer from coming back while making treatment easier to tolerate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin (chemotherapy) and radiation therapy (IMRT or IMPT)
- What this could lead to
- If successful, this approach could lead to a less toxic treatment plan for HPV-related throat cancer, reducing weight loss, feeding tube use, and other side effects without sacrificing cancer control.
- What could go wrong
- This is a small, single-arm Phase 2 trial with no comparison group, so it cannot prove that the reduced treatment is as effective as standard care. The results may not apply to all patients, and there is still a risk of cancer recurrence.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
63 people
The number who actually took part.
- Started
-
Oct 2018
- Finished
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Mar 2026
- 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
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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: * Histologically or cytologically confirmed HPV-related stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results. * Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery) * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. * Normal organ and marrow function defined as: * Creatinine clearance \> 50 cc/min. * ANC \> 1,000/mcL. * Platelet count \>100,000/mcL. * At least 18 years of age. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Prior curative therapy for HNSCC. * Patient must not have known distant metastatic disease at presentation. * History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year overall survival (OS) \> 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b). * Receiving any other investigational agents. * Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.
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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
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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