Oropharyngeal CancersLombardi197NCT06902623
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
A study testing Radiation in people with Oropharyngeal Cancers and HPV, run by Georgetown University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancers, HPV, Tonsil Cancer
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nicole Swanson contact
United States2 sites, 2 recruiting
- Recruiting
Medstar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Peter H Ahn, MD, 202-444-6385, peter.h.ahn@gunet.georgetown.edu
Peter H Ahn, MD
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Peter H Ahn, MD, 202-444-6385, peter.h.ahn@gunet.georgetown.edu
Peter H Ahn, MD
About this study
Official title: A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
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.
Read the detailed description
This study aims to estimate the efficacy of radiation dose de-escalation while omitting chemotherapy for favorable prognosis HPV or p16-positive oropharyngeal cancer patients receiving definitive radiation therapy, where efficacy is measured by 2-year progression free survival (PFS) rate after treatment de-escalation for low-risk HPV+ oropharyngeal squamous cell carcinoma. This study also aims to determine quality of life parameters, complete clinical and radiographic response, as well as local, regional and distant metastasis control as well as overall survival.
- Conditions
- Oropharyngeal Cancers, HPV, Tonsil Cancer, Base of Tongue Cancer
- Being tested
- Radiation
- Medical subject headings
- Oropharyngeal Neoplasms, Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Radiation only to 66Gy
| Study group | Role | What they receive |
|---|---|---|
| Radiation only | Experimental | Radiation therapy only to a dose of 66Gy to gross disease Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression Free Survival- 2-year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.
Measured: 2 years
Secondary outcomes (8)
Local Control of disease (LC) rate
Number of patient with local control at 2 years, as determined by standard of care physical examination and/or standard of care surveillance imaging.
Measured: 2 years
Regional Control of diseaes (RC) rate
Number of patient with regional control at 2 years, as determined by standard of care physical examination and/or standard of care surveillance imaging.
Measured: 2 years
Distant Metastasis-Free Survival (DMFS) rate
Distant Metastasis-Free Survival as determined by standard of care physical examination and standard of care surveillance imaging at 2 years.
Measured: 2 years
Overall Survival (OS)
Defined a time from start of treatment until end of study or death.
Measured: 2 years
Quality of life (QOL) Core Questionnaire
Estimate differences in quality of life (QOL) parameters between patients treated with intensity-modulated photon radiation therapy versus proton beam radiation therapy (RT) related to radiation dose to organs at risk (OAR). QOL will be measured by validated questionnaires relating to patient related outcomes. Completed at baseline, and then at 1-2 weeks, 3 months, 6, 12, 18 and 24 months after completion of RT. EORTC QLQ Core Questionnaire (EORTC QLQ-C30), scale 0-100 with 100 being the best outcome.
Measured: 2 years
Quality of life (QOL) Head and Neck Cancer
Estimate differences in quality of life (QOL) parameters between patients treated with intensity-modulated photon radiation therapy versus proton beam radiation therapy (RT) related to radiation dose to organs at risk (OAR). QOL will be measured by validated questionnaires relating to patient related outcomes. Completed at baseline, and then at 1-2 weeks, 3 months, 6, 12, 18 and 24 months after completion of RT. Head and Neck Cancer (QLQ-H\&N35), scale 0-100 with 100 being the best outcome.
Measured: 2 years
Rate of percutaneous endocsopic gastrostomy (PEG) tube placement
Number of patients with PEG tube placement and presence of PEG tube at 1 year in patients who are treated with de-escalated definitive radiotherapy.
Measured: 1 year
Rate of neck dissection
Number of subjects with neck dissection within 12 weeks of treatment completion due to equivocal examination findings, even if the neck dissection shows no residual disease.
Measured: 12 weeks post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Aug 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancersStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Ahn, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902623
- Sponsor's protocol ID
- STUDY00000197
- Acronym
- Lombardi197
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
- ClinicalTrials.gov ID
- NCT06902623
- Acronym / sponsor ID
- Lombardi197 / STUDY00000197
- Conditions
- Oropharyngeal Cancers, HPV, Tonsil Cancer, Base of Tongue Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to estimate the efficacy of radiation dose de-escalation while omitting chemotherapy for favorable prognosis HPV or p16-positive oropharyngeal cancer patients receiving definitive radiation therapy, where efficacy is measured by 2-year progression free survival (PFS) rate after treatment de-escalation for low-risk HPV+ oropharyngeal squamous cell carcinoma. This study also aims to determine quality of life parameters, complete clinical and radiographic response, as well as local, regional and distant metastasis control as well as overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation only | Experimental | Radiation: RadiationRadiation therapy only to a dose of 66Gy to gross disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationRadiation only to 66Gy | Radiation | Radiation only |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 years
Progression Free Survival- 2-year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.
8 secondary outcomes
Local Control of disease (LC) rate
Time frame: 2 years
Regional Control of diseaes (RC) rate
Time frame: 2 years
Distant Metastasis-Free Survival (DMFS) rate
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Quality of life (QOL) Core Questionnaire
Time frame: 2 years
Quality of life (QOL) Head and Neck Cancer
Time frame: 2 years
Rate of percutaneous endocsopic gastrostomy (PEG) tube placement
Time frame: 1 year
Rate of neck dissection
Time frame: 12 weeks post treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Swanson contact
Peter Ahn, MD principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation in people with Oropharyngeal Cancers and HPV, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter H Ahn, MD (202-444-6385, peter.h.ahn@gunet.georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.