New radiation combo aims to shrink oral tumors before surgery
NCT ID NCT07335380
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new type of radiation (lattice radiotherapy) given with chemotherapy and immunotherapy before surgery for oral cavity cancer. About 30 adults with advanced but removable tumors will receive different radiation doses to find the safest level. The goal is to see if this combination can shrink tumors more effectively before surgery, while monitoring side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- 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: * Non-metastatic, pathologically confirmed oral cavity squamous cell carcinoma, cT3-T4a cN0-N3 or cT1-T2 cN1-N3. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma, e.g.). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oral cavity (oral tongue, floor of mouth, alveolar ridge, buccal or lip, i.e.) * Surgically resectable * Zubrod Performance Status of 0-1 * (Phase I) Primary and lymph node ≥ 3 cm * (Phase II) Primary and lymph node ≥ 3 cm OR Primary ≥ 3 cm * Patients must provide their personal smoking history prior to registration. * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include: intrauterine device (IUD)/intrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable). * Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception (abstinence/protection) for the duration of treatment/study participation. * The patient must provide study-specific informed consent prior to study entry. * Adequate renal function within 2 weeks prior to registration * Adequate hematologic function within 2 weeks prior to registration * Patients who are HIV positive but who have no prior AIDS-defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). Exclusion Criteria: * Cancers considered to be primarily located in the oropharynx even if p16 negative * Carcinoma of the neck of unknown primary site origin (even if p16 negative) * Distant metastasis or adenopathy below the clavicles; * Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. * Simultaneous primary cancers or separate bilateral primary tumor sites; * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; * Severe, active co-morbidity * Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic * Prior allergic reaction to cisplatin * Exclusion Criteria for MRI: Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion. 1. Electrical implants such as cardiac pacemakers or perfusion pumps 2. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants 3. Ferromagnetic objects such as jewelry or metal clips in clothing 4. Claustrophobia 5. History of seizures
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
New York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can tumor genetics unlock gentler treatments for head and neck cancer?
- Aiming to spare the neck: could smarter radiation cut side effects in oral cancer?
- Less neck surgery may be just as effective for oral cancer with one affected node
- Bee product may boost health in oral cancer survivors
- Acupuncture timing may be key to preventing dry mouth in head and neck cancer patients