Oropharyngeal CarcinomaPhase 2NCT03215719
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
A Phase 2 study testing Standard Radiation Treatment, Dose-Deescalated Treatment and Cisplatinum in people with Oropharyngeal Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Standard Radiation Treatment, Dose-Deescalated Treatment and Cisplatinum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to Dec 2028
- Phase
- Phase 2
- 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
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.
- If the primary site is biopsied, Patient's tissue must be positive for p16 by immunohistochemical staining (>70% staining). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is not available for p16 immunohistochemistry.
- Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary site is biopsied. Must have detectable screening plasma HPV DNA (also referred to as ctHPV DNA).
- Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases based on the following diagnostic workup:
- Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration.
- One of the following combinations of imaging is required within 8 weeks of registration:
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- CT scan of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast);
- Or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast)
- Note: A CT scan of the neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools.
- Patients must provide their personal smoking history prior to registration. Patients cannot have a cumulative personal smoking history that exceeds 10 pack-years.
- Number of pack-years = [Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)] / 20
- Note: Twenty cigarettes is considered equivalent to one pack. Cigar and pipe tobacco consumption is not included in calculating lifetime pack-years.
- Zubrod Performance Status of 0-1 within 8 weeks prior to registration;
- Adequate hematologic function within 2 weeks 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 2 weeks prior to registration, defined as follows:
- a.Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24 hour collection or estimated by Cockcorft-Gault formula: i.CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] ii.CCr female = 0.85 x (CrCl male)
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
- 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).
- The patient must provide study-specific informed consent prior to study entry.
Who cannot join
- Missing or undetectable baseline plasma HPV DNA level
- Cancers considered to be from an oral cavity site (oral tongue, floor of 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);
- 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;
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- 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 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 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 listed in 4.1.10.
- Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition with immune compromise greater than that noted in section 4.1.12; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.
- 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.
- Electrical implants such as cardiac pacemakers or perfusion pumps
- 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
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Claustrophobia
- History of seizures
- Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will not have DCE-MRI scan. These patients will have conventional anatomical MRI without contrast.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fraustina Hsu contact
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Kenneth Hu, 212-731-5003, Kenneth.Hu@nyulangone.org
Kenneth Hu, MD
About this study
Official title: Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Read the detailed description
The secondary objectives will include 2-year loco-regional control and overall survival, quality of life, and late toxicity. Quality of life outcomes will be assessed with a validated, self-reported questionnaire. Late toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes.
- Being tested
- Standard Radiation Treatment, Dose-Deescalated Treatment, Cisplatinum
- Keywords
- Radiation Therapy
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Radiation TreatmentRadiation
An interval scan at 4 weeks to assess for a good response defined as >40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (>40% nodal shrinkage). Those with nodal shrinkage and clearance of circulating plasma HPV DNA shall undergo further treatment de-escalation.
Dose-Deescalated TreatmentRadiation
Also called Intensity Modulated Radiation Therapy (IMRT)
Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons
CisplatinumDrug
Standard of care chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dose de-escalation (6 weeks) | Experimental | 26 participants demonstrating a favorable response defined as >40% nodal shrinkage were eligible to receive the de-escalated treatment regimen (6 doses of weekly cisplatinum with 6 weeks of radiation to a total dose of 60Gy).
This arm is closed and has been replaced with Arm 3. Receives: Radiation: Dose-Deescalated Treatment; Drug: Cisplatinum |
| Arm 2: Standard radiation therapy + cisplatinum (7 weeks) | Active comparator | Participants will receive standard radiation therapy and cisplatinum for 7 weeks. Receives: Radiation: Standard Radiation Treatment; Radiation: Dose-Deescalated Treatment; Drug: Cisplatinum |
| Arm 3: Dose de-escalation (6 weeks) | Experimental | For participants who achieve (a) rapid nodal shrinkage on interval CT scan but slow / unknown ctHPV DNA clearance OR (b) slow nodal shrinkage on interval CT scan but rapid ctHPV DNA clearance at week 4, radiation treatment will be de-escalated to a total dose of 60Gy/6 weeks with 6 doses of weekly (cisplatinum).
This arm replaced Arm 1. Receives: Radiation: Dose-Deescalated Treatment; Drug: Cisplatinum |
| Arm 4: Dose de-escalation (5 weeks) | Experimental | For participants who achieve both a favorable nodal response (>40%) on interval CT scan as well as rapid ctHPV DNA clearance at week 4, radiation treatment will be further de-escalated to a total dose of 50 Gy/5 weeks with 5 doses of weekly cisplatinum). Receives: Radiation: Dose-Deescalated Treatment; Drug: Cisplatinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 2 years
The non-inferiority (NI) analysis will be conducted on the pooled de-escalated cohort (Arms 3+4 combined) to evaluate whether the 2-year PFS is acceptable relative to the historical benchmark. For Arm 3 and Arm 4 separately, Kaplan-Meier curves and 2-year PFS estimates with 95% confidence intervals will be provided. Patients who do not experience progression of disease and have not died will be censored on the date of last follow up.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start18 Oct 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Hu, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215719
- Sponsor's protocol ID
- 17-00330
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2017
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive De-escalation of Radiation Therapy Dose in HPV-Positive Oropharyngeal Carcinoma (ART) Demonstrating Favorable Mid-Treatment Response
- ClinicalTrials.gov ID
- NCT03215719
- Acronym / sponsor ID
- 17-00330
- Keywords
- Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Jul 2017 (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.
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Detailed description
The secondary objectives will include 2-year loco-regional control and overall survival, quality of life, and late toxicity. Quality of life outcomes will be assessed with a validated, self-reported questionnaire. Late toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose de-escalation (6 weeks) | Experimental | Radiation: Dose-Deescalated Treatment, Drug: Cisplatinum26 participants demonstrating a favorable response defined as >40% nodal shrinkage were eligible to receive the de-escalated treatment regimen (6 doses of weekly cisplatinum with 6 weeks of radiation to a total dose of 60Gy). This arm is closed and has been replaced with Arm 3. |
| Arm 2: Standard radiation therapy + cisplatinum (7 weeks) | Active comparator | Radiation: Standard Radiation Treatment, Radiation: Dose-Deescalated Treatment, Drug: CisplatinumParticipants will receive standard radiation therapy and cisplatinum for 7 weeks. |
| Arm 3: Dose de-escalation (6 weeks) | Experimental | Radiation: Dose-Deescalated Treatment, Drug: CisplatinumFor participants who achieve (a) rapid nodal shrinkage on interval CT scan but slow / unknown ctHPV DNA clearance OR (b) slow nodal shrinkage on interval CT scan but rapid ctHPV DNA clearance at week 4, radiation treatment will be de-escalated to a total dose of 60Gy/6 weeks with 6 doses of weekly (cisplatinum). This arm replaced Arm 1. |
| Arm 4: Dose de-escalation (5 weeks) | Experimental | Radiation: Dose-Deescalated Treatment, Drug: CisplatinumFor participants who achieve both a favorable nodal response (>40%) on interval CT scan as well as rapid ctHPV DNA clearance at week 4, radiation treatment will be further de-escalated to a total dose of 50 Gy/5 weeks with 5 doses of weekly cisplatinum). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.
- If the primary site is biopsied, Patient's tissue must be positive for p16 by immunohistochemical staining (>70% staining). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is not available for p16 immunohistochemistry.
- Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary site is biopsied. Must have detectable screening plasma HPV DNA (also referred to as ctHPV DNA).
- Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases based on the following diagnostic workup:
- Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration.
Key exclusion criteria (25 listed)
- Missing or undetectable baseline plasma HPV DNA level
- Cancers considered to be from an oral cavity site (oral tongue, floor of 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);
- 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.
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 |
|---|---|---|
| Standard Radiation TreatmentAn interval scan at 4 weeks to assess for a good response defined as >40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (>40% nodal shrinkage). Those with nodal shrinkage and clearance of circulating plasma HPV DNA shall undergo further treatment de-escalation. | Radiation | Arm 2: Standard radiation therapy + cisplatinum (7 weeks) |
| Dose-Deescalated TreatmentAlso: Intensity Modulated Radiation Therapy (IMRT)Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons | Radiation | Arm 1: Dose de-escalation (6 weeks), Arm 2: Standard radiation therapy + cisplatinum (7 weeks), Arm 3: Dose de-escalation (6 weeks), Arm 4: Dose de-escalation (5 weeks) |
| CisplatinumStandard of care chemotherapy | Drug | Arm 1: Dose de-escalation (6 weeks), Arm 2: Standard radiation therapy + cisplatinum (7 weeks), Arm 3: Dose de-escalation (6 weeks), Arm 4: Dose de-escalation (5 weeks) |
Primary outcome
Progression-free survival at 2 years
Time frame: 2 Years
The non-inferiority (NI) analysis will be conducted on the pooled de-escalated cohort (Arms 3+4 combined) to evaluate whether the 2-year PFS is acceptable relative to the historical benchmark. For Arm 3 and Arm 4 separately, Kaplan-Meier curves and 2-year PFS estimates with 95% confidence intervals will be provided. Patients who do not experience progression of disease and have not died will be censored on the date of last follow up.
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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Fraustina Hsu contact
Kenneth Hu, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Radiation Treatment, Dose-Deescalated Treatment and Cisplatinum in people with Oropharyngeal Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by NYU Langone Health at 1 site 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 20 inclusion and 25 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kenneth Hu (212-731-5003, Kenneth.Hu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival at 2 years (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 6 Jan 2026.