NCT06902623 Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
| NCT ID | NCT06902623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Oropharyngeal Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2019-08-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.
Eligibility Criteria
Inclusion Criteria: * Patients must be ≥ 18 years of age on the day of signing informed consent. * Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall). * clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tumor for biopsy/sample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind. * Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment. * Patients must have Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration * Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration. * Patient must have had a hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal. * Patients must be a current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Patients with gross involvement of level 4 lymph node level * Endophytic T3 disease, as clinically determined by the principal investigator. * Patients with any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed) * Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed) * Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free, or Gleason 6 prostate cancer undergoing active surveillance. * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Contact & Investigator
Peter Ahn, MD
PRINCIPAL INVESTIGATOR
Georgetown University
Frequently Asked Questions
Who can join the NCT06902623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharyngeal Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06902623 currently recruiting?
Yes, NCT06902623 is actively recruiting participants. Contact the research team at peter.h.ahn@gunet.georgetown.edu for enrollment information.
Where is the NCT06902623 trial being conducted?
This trial is being conducted at Washington D.C., United States, Clinton, United States.
Who is sponsoring the NCT06902623 clinical trial?
NCT06902623 is sponsored by Georgetown University. The principal investigator is Peter Ahn, MD at Georgetown University. The trial plans to enroll 30 participants.
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