Testing Less Intensive Radiation with Chemotherapy for HPV-Positive Oropharyngeal Cancer
This study is testing a new way to treat HPV-positive oropharyngeal cancer (a type of throat cancer). It combines standard chemotherapy (Cisplatin injection) with radiation therapy. The goal is to give the usual dose of radiation to cancer sites and involved lymph nodes, but a lower dose to lymph nodes that don't show cancer. Researchers hope this approach will control the cancer just as well as standard treatment, but lead to fewer long-term side effects like dry mouth (xerostomia) and difficulty swallowing (dysphagia), improving your quality of life after treatment. This study is for adults aged 18 and older with HPV-positive oropharyngeal cancer. The main way they will measure success is by looking at how many people need a PEG tube (a feeding tube) during the procedure. The study plans to enroll 28 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.
- What's involved
- Patients must have the psychological ability and general health to complete study requirements and follow-up. Women of childbearing potential and sexually active men must use acceptable contraception during treatment and for at least 60 days afterward.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
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NCT04444869
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Missouri-ColumbiaInvestigator-initiated
~28 participants
Updated 2024-05-17 on ClinicalTrials.gov
What's tested:Cisplatin injection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of PEG tube placement
Measured over During the procedure
Conditions
NCT04444869
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Missouri
Columbia, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Gregory Biedermann, MD · PRINCIPAL_INVESTIGATOR · University of Missouri - Ellis Fischel Cancer Center
Who to contact
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Eligibility criteria
Inclusion
Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
General history and physical examination within 30 days prior to registration;
Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration;
One of the following combinations of imaging is required within 45 days prior to registration:
Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.
Zubrod Performance Status of 0-1 within 30 days prior to registration;
Adequate hematologic function within 14 days prior to registration, defined as follows:
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
Platelets ≥ 100,000 cells/mm3;
Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.
Adequate renal function within 14 days prior to registration, defined as follows:
Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
Adequate hepatic function within 14 days prior to registration defined as follows:
Bilirubin \< 2 mg/dl;
AST or ALT \< 3 x the upper limit of normal.
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Exclusion
Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
Carcinoma of the neck of unknown primary site origin (even if p16 positive);
T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
Radiographically matted nodes, that span 6 cm or more; N3 disease
Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
Definitive clinical or radiologic evidence of metastatic disease 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 5 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 defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
Transmural myocardial infarction within the last 6 months;
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.
What this trial measures
- Rate of PEG tube placementDuring the procedure
To determine rate of PEG tube placement