Head and Neck CancerPhase 2SAVALNCT06088381
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
A Phase 2 study testing Experimental Observation and Circulating Tumor DNA test (ctDNA test) in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Maryland, Baltimore at 5 sites in United States.
Trial summary
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer
- What is being tested?
- Experimental Observation and Circulating Tumor DNA test (ctDNA test)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Mar 2024to 18 Dec 2030
- 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
- Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.
- Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT) with imaging within 60 days of enrollment?
- Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?
- Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board?
- Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?
- Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?
Show all 9Show fewer
- Is the patient ≥ 18 years of age?
- If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.
- Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?
Who cannot join
- Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?
- Does the patient have distant metastasis?
- Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years?
- Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?
- Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?
- Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies?
Show all 9Show fewer
- Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?
- Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?
- Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Kelly Kitzmiller, 410-369-5246, kelly.kitzmiller@umm.edu
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Kelly Kitzmiller, BS, 410-369-5246, kelly.kitzmiller@umm.edu
- Not yet recruiting
Upper Chesapeake Health
Bel Air, Maryland, 21014
Lalicia Roman, 443-643-1877, lalicia.roman@umm.edu
- Not yet recruiting
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Kelly Kitzmiller, 410-369-5246, kelly.kitzmiller@umm.edu
- Not yet recruiting
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Pilar Strycula, P.Strycula@umm.edu
Pilar
About this study
Official title: A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment.
The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.
Read the detailed description
Patients with human papillomavirus (HPV) or its surrogate marker p16, positive oropharyngeal squamous cell carcinoma (hereafter p16+OPSCC) exhibit favorable overall survival rates of 70-100% at 3 years. These outcomes are dependent on disease burden and patient characteristics and independent of treatment modality. Significant treatment related side effects exist despite advances in radiotherapy technology, surgical techniques, and supportive care. In addition to common acute toxicities, their favorable overall survival potentially places these patients at increased risk for developing long-term treatment-induced side-effects. Therefore, it is important to establish novel management approaches that maintain excellent current clinical outcomes while effectively reducing acute and long-term side effects.
The de-escalation trials for surgical management have explored various combinations of dose-reduction, while preserving favorable oncologic outcomes for patients. Prospective trials have demonstrated efficacy, safety, and functional benefit following treatment reduction to the primary tumor, regional lymph node metastasis, and the elective nodal volume. Therefore, newer approaches of combining the treatment modifications from each of these treatment fields offer the potential to have substantial harm reduction for future patients.
Cell free HPV tumor DNA (ctDNA) has emerged as a method to monitor the presence of disease and is a promising biomarker. Changes in expression of ctDNA post treatment with TransOral Robotic Surgery (TORS) or radiation therapy (RT) with or without chemotherapy are observed and clearance of ctDNA is associated with a favorable prognosis. These promising findings have led several groups to initiate clinical trials evaluating observation in patients after definitive oropharyngeal cancer removal and subsequent clearance of ctDNA levels. Data suggests that patients who initially undergo observation following TORS have similar rates of distant metastases and favorable rates of salvage. To date, an observation-based approach has not been adopted for intermediate risk patients due to challenges identifying optimal cohorts for observation and concern for increased treatment related toxicity for patients who do require salvage. In this trial, the investigators propose use of ctDNA clearance to identify patients who are optimal for observation. This protocol tests the hypothesis that patients currently recommended for adjuvant RT based on intermediate risk factors can be observed post-TORS when ctDNA is cleared.
Patients with p16+OPSCC who are candidates for surgery (TORS) and have positive ctDNA will be offered registration for the study prior to surgical resection. After TORS, all patients will have ctDNA drawn within 2-14 days post operatively. Combined with pathological criteria, all patients will be stratified into one three risk groups; low risk, intermediate risk, high risk. The low risk group will be observed (no radiation) per standard of care (SOC). The intermediate group (intermediate pathological features and negative ctDNA) will also be observed (no radiation) per the experimental arm. The high risk group will receive adjuvant treatment (RT +/- chemotherapy) per SOC.
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Experimental Observation, Observation per Standard of Care, Adjuvant Treatment per Standard of Care, Circulating Tumor DNA test (ctDNA test)
- Keywords
- Transoral Robotic Surgery (TORS), Head and Neck Cancer, Oropharynx Cancer, HPV p16 Oropharynx Cancer, Proton Therapy, Photon Therapy
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ObservationOther
Patients on the experimental arm will be under observation only.
Observation per Standard of CareOther
The low-risk group of patients will be observed per standard of care.
Adjuvant Treatment per Standard of CareRadiation
The high-risk group of patients will receive adjuvant treatment per standard of care (Radiation with or without chemotherapy)
Circulating Tumor DNA test (ctDNA test)Diagnostic test
Blood test for diagnostic and surveillance purposes measuring expression of Cell free HPV tumor DNA (ctDNA) in the blood. Patients will undergo ctDNA within 90 days pre-transoral robotic surgery(TORS), 2-14 days post TORS, then every 3 months (except for at 21 months) for 2 year post completion of initial therapy or salvage therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Risk Experimental Observation | Experimental | Requires the following criteria:
1. Pathological T1-3 N1-2 with negative surgical margins
2. Absent or microscopic extracapsular extension(ECE) (≤1mm)
3. ctDNA positive pre-operatively and negative post-operatively
This group will undergo observation on the experimental arm of the study. They will be monitored for toxicity, Quality of Life (QoL) and outcomes evaluation. Suspected locoregional recurrence (LRR) based on physical examination, imaging or increasing ctDNA will undergo completion of workup at the discretion of the University of Maryland Head and Neck tumor board. LRR will be offered salvage treatment based on recommendations from multi-disciplinary discussion. Salvage therapy could include surgical resection (with or without adjuvant treatment), and definitive RT (with or without chemotherapy). Receives: Other: Experimental Observation; Other: Observation per Standard of Care; Radiation: Adjuvant Treatment per Standard of Care; Diagnostic Test: Circulating Tumor DNA test (ctDNA test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Percent PFS at 2 year post last treatment inclusive of patients undergoing salvage treatment for LRR.
Measured: 2 year post last treatment
Secondary outcomes (9)
Rate of Recurrence
Rate of recurrence at one year post TORS with negative ctDNA
Measured: 1 year post TORS
Rate of Salvage
Rate of salvage for locoregional recurrence (LRR) after TORS
Measured: 2 years post TORS
Locoregional recurrence (LRR)
Measured: 2 year post last treatment
Overall Survival (OS)
Measured: 2 year post last treatment
Number of participants free from distant metastases
Freedom from Distant Metastases (FFDM) at 2 years post last treatment
Measured: 2 year post last treatment
Number of participants with grade 2/3 xerostomia
defined by PRO-CTCAE (patient-reported outcome (PRO) measurement system - Common Terminology Criteria for Adverse Events (CTCAE))
Measured: 1-year following completion of treatment
Patient scores from the questionnaire called The Monroe Dunaway Anderson Dysphagia Inventory (MDADI)
The M.D. Anderson Dysphagia Inventory is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the Quality of Life (QOL) of patients with head and neck cancer.
Two scores are obtained: a Global Score and a Composite Score. Global Score ranges from 1 (extremely low functioning) to 5 (high functioning) Composite Score ranges from 20 (extremely low functioning) to 100 (high functioning)
Measured: 1-year following completion of treatment
PEG-tube rate
Percutaneous endoscopic gastrostomy (PEG)-tube rate
Measured: 2-year following completion of treatment
Rate of recurrence in all patients (Groups 1, 2 and 3) stratified by group and post TORS ctDNA levels
Rate of recurrence stratified by group and post TORS ctDNA levels
Measured: 1 year post TORS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start7 Mar 2024
- Primary completion18 Dec 2028 (estimated)
- Study completion18 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Molitoris, MD PhD, University of Maryland, Baltimore
- Investigators
- Jason K Molitoris, MD, PhD, Principal investigator, University of Maryland/Maryland Proton Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088381
- Sponsor's protocol ID
- HP-00106914
- Acronym
- SAVAL
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
- ClinicalTrials.gov ID
- NCT06088381
- Acronym / sponsor ID
- SAVAL / HP-00106914
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Keywords
- Transoral Robotic Surgery (TORS), Head and Neck Cancer, Oropharynx Cancer, HPV p16 Oropharynx Cancer, Proton Therapy, Photon Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 18 Dec 2028 (estimated)
- Study completion
- 18 Dec 2030 (estimated)
- First posted
- 18 Oct 2023 (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.
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment.
The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.
Detailed description
Patients with human papillomavirus (HPV) or its surrogate marker p16, positive oropharyngeal squamous cell carcinoma (hereafter p16+OPSCC) exhibit favorable overall survival rates of 70-100% at 3 years. These outcomes are dependent on disease burden and patient characteristics and independent of treatment modality. Significant treatment related side effects exist despite advances in radiotherapy technology, surgical techniques, and supportive care. In addition to common acute toxicities, their favorable overall survival potentially places these patients at increased risk for developing long-term treatment-induced side-effects. Therefore, it is important to establish novel management approaches that maintain excellent current clinical outcomes while effectively reducing acute and long-term side effects.
The de-escalation trials for surgical management have explored various combinations of dose-reduction, while preserving favorable oncologic outcomes for patients. Prospective trials have demonstrated efficacy, safety, and functional benefit following treatment reduction to the primary tumor, regional lymph node metastasis, and the elective nodal volume. Therefore, newer approaches of combining the treatment modifications from each of these treatment fields offer the potential to have substantial harm reduction for future patients.
Cell free HPV tumor DNA (ctDNA) has emerged as a method to monitor the presence of disease and is a promising biomarker. Changes in expression of ctDNA post treatment with TransOral Robotic Surgery (TORS) or radiation therapy (RT) with or without chemotherapy are observed and clearance of ctDNA is associated with a favorable prognosis. These promising findings have led several groups to initiate clinical trials evaluating observation in patients after definitive oropharyngeal cancer removal and subsequent clearance of ctDNA levels. Data suggests that patients who initially undergo observation following TORS have similar rates of distant metastases and favorable rates of salvage. To date, an observation-based approach has not been adopted for intermediate risk patients due to challenges identifying optimal cohorts for observation and concern for increased treatment related toxicity for patients who do require salvage. In this trial, the investigators propose use of ctDNA clearance to identify patients who are optimal for observation. This protocol tests the hypothesis that patients currently recommended for adjuvant RT based on intermediate risk factors can be observed post-TORS when ctDNA is cleared.
Patients with p16+OPSCC who are candidates for surgery (TORS) and have positive ctDNA will be offered registration for the study prior to surgical resection. After TORS, all patients will have ctDNA drawn within 2-14 days post operatively. Combined with pathological criteria, all patients will be stratified into one three risk groups; low risk, intermediate risk, high risk. The low risk group will be observed (no radiation) per standard of care (SOC). The intermediate group (intermediate pathological features and negative ctDNA) will also be observed (no radiation) per the experimental arm. The high risk group will receive adjuvant treatment (RT +/- chemotherapy) per SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermediate Risk Experimental Observation | Experimental | Other: Experimental Observation, Other: Observation per Standard of Care, Radiation: Adjuvant Treatment per Standard of Care, Diagnostic Test: Circulating Tumor DNA test (ctDNA test)Requires the following criteria: 1. Pathological T1-3 N1-2 with negative surgical margins 2. Absent or microscopic extracapsular extension(ECE) (≤1mm) 3. ctDNA positive pre-operatively and negative post-operatively This group will undergo observation on the experimental arm of the study. They will be monitored for toxicity, Quality of Life (QoL) and outcomes evaluation. Suspected locoregional recurrence (LRR) based on physical examination, imaging or increasing ctDNA will undergo completion of workup at the discretion of the University of Maryland Head and Neck tumor board. LRR will be offered salvage treatment based on recommendations from multi-disciplinary discussion. Salvage therapy could include surgical resection (with or without adjuvant treatment), and definitive RT (with or without chemotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.
- Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT) with imaging within 60 days of enrollment?
- Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?
- Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board?
- Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?
Key exclusion criteria (9 listed)
- Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?
- Does the patient have distant metastasis?
- Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years?
- Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?
- Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?
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 |
|---|---|---|
| Experimental ObservationPatients on the experimental arm will be under observation only. | Other | Intermediate Risk Experimental Observation |
| Observation per Standard of CareThe low-risk group of patients will be observed per standard of care. | Other | Intermediate Risk Experimental Observation |
| Adjuvant Treatment per Standard of CareThe high-risk group of patients will receive adjuvant treatment per standard of care (Radiation with or without chemotherapy) | Radiation | Intermediate Risk Experimental Observation |
| Circulating Tumor DNA test (ctDNA test)Blood test for diagnostic and surveillance purposes measuring expression of Cell free HPV tumor DNA (ctDNA) in the blood. Patients will undergo ctDNA within 90 days pre-transoral robotic surgery(TORS), 2-14 days post TORS, then every 3 months (except for at 21 months) for 2 year post completion of initial therapy or salvage therapy. | Diagnostic test | Intermediate Risk Experimental Observation |
Primary outcome
Progression-free Survival (PFS)
Time frame: 2 year post last treatment
Percent PFS at 2 year post last treatment inclusive of patients undergoing salvage treatment for LRR.
9 secondary outcomes
Rate of Recurrence
Time frame: 1 year post TORS
Rate of Salvage
Time frame: 2 years post TORS
Locoregional recurrence (LRR)
Time frame: 2 year post last treatment
Overall Survival (OS)
Time frame: 2 year post last treatment
Number of participants free from distant metastases
Time frame: 2 year post last treatment
Number of participants with grade 2/3 xerostomia
Time frame: 1-year following completion of treatment
Patient scores from the questionnaire called The Monroe Dunaway Anderson Dysphagia Inventory (MDADI)
Time frame: 1-year following completion of treatment
PEG-tube rate
Time frame: 2-year following completion of treatment
Rate of recurrence in all patients (Groups 1, 2 and 3) stratified by group and post TORS ctDNA levels
Time frame: 1 year post TORS
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 10 Nov 2025.
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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.
Jason K Molitoris, MD, PhD principal investigator
University of Maryland/Maryland Proton Treatment Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental Observation and Circulating Tumor DNA test (ctDNA test) in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University of Maryland, Baltimore at 5 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 9 inclusion and 9 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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 Jason K Molitoris, MD, PhD (410-328-6080, jmolitoris@umm.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 year post last treatment). 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 10 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.