Oropharynx CancerPhase 2NCT03416153
Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer
A Phase 2 study testing Carboplatin, Radiation Therapy and Paclitaxel in people with Oropharynx Cancer, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial summary
This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Carboplatin, Radiation Therapy and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2018to 5 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 have FDG-avid and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization.
- AJCC eighth edition staging stage 1 and stage 2
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of weight within 4 weeks prior to registration;
- FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;
- Zubrod Performance Status (A quantification of the functional status of cancer patients that runs from 0 to 5, with 0 denoting perfect health and 5 death) 0-1 within 4 weeks prior to registration;
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- Age ≥ 18;
- Able to tolerate PET/CT imaging required to be performed
- CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function;
- Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 ml/min within 4 weeks prior to registration;
- Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
- The patient must provide study-specific informed consent prior to study entry.
Who cannot join
- cT4, cN3 or cM1 disease
- "Matted nodes" as determined by review with Neuroradiology
- Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
- Carcinoma of the neck of unknown primary site origin (even if p16 positive);
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if > 3 years prior to study;
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- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Severe, active co-morbidity;
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception;
- Poorly controlled diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48109
About this study
Official title: A Multi-Center Phase II Trial of Individualized Adaptive De-escalated Radiotherapy Using Pre and Mid-Treatment FDG-PET/CT for HPV-related Oropharynx Cancer
This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.
- Conditions
- Oropharynx Cancer
- Being tested
- Carboplatin, Radiation Therapy, Paclitaxel
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation TherapyRadiation
Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
PaclitaxelDrug
30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Patients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) Receives: Drug: Carboplatin; Radiation: Radiation Therapy; Drug: Paclitaxel |
| De-escalation Treatment | Experimental | Patients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. Receives: Drug: Carboplatin; Radiation: Radiation Therapy; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease
RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.
Measured: 1 Year
Change in Metabolic Tumor Volume 50% (MTV 50%)
The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model.
Measured: 2 months
Secondary outcomes (5)
Patterns of Failure
Kaplan-Meier estimate of the percentage of participants who experienced Locoregional relapse versus distant relapse
Measured: at 3 months and 2 years
Overall Survival
Kaplan-Meier estimate of the percentage of participants who are still alive at 3 months and 2 years.
Measured: at 3 months, and 2 Years
Progression- Free Survival
Kaplan-Meier estimate of the percentage of participants who are still in progression free survival at 3 months and 2 years
Measured: at 3 months and 2 years
Incidence of Toxicity
Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 1, 3 and 12 months. XQ, Xerostomia Questionnaire, is scored on a scale of 0-100 with higher score indicating worse xerostomia. HN, FACT-HN, is scored on a scale of 0-190 with higher score indicating a better quality of life.
Measured: 1, 3 and 12 months
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Median values of ctDNA molecules present throughout the study. The week 6/7 measurement is taken as the first measurement that was available during weeks 6 and 7 to minimize missing data and to account for minor timing deviations in sample collection during weeks 6 and 7
Measured: from Baseline up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start21 May 2018
- Primary completion5 May 2023
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- VA Ann Arbor Healthcare System, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michelle Mierzwa, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416153
- Sponsor's protocol ID
- UMCC 2017.113
- Other IDs
- HUM00136258, U01CA183848
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2018
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase II Trial of Individualized Adaptive De-escalated Radiotherapy Using Pre and Mid-Treatment FDG-PET/CT for HPV-related Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT03416153
- Acronym / sponsor ID
- UMCC 2017.113
- Conditions
- Oropharynx Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- VA Ann Arbor Healthcare System, National Cancer Institute (NCI)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 22 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: Carboplatin, Radiation: Radiation Therapy, Drug: PaclitaxelPatients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) |
| De-escalation Treatment | Experimental | Drug: Carboplatin, Radiation: Radiation Therapy, Drug: PaclitaxelPatients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have FDG-avid and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization.
- AJCC eighth edition staging stage 1 and stage 2
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of weight within 4 weeks prior to registration;
- FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;
Key exclusion criteria (10 listed)
- cT4, cN3 or cM1 disease
- "Matted nodes" as determined by review with Neuroradiology
- Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
- Carcinoma of the neck of unknown primary site origin (even if p16 positive);
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
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 |
|---|---|---|
| CarboplatinAUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. | Drug | De-escalation Treatment, Standard Treatment |
| Radiation TherapyPatients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. | Radiation | De-escalation Treatment, Standard Treatment |
| Paclitaxel30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. | Drug | De-escalation Treatment, Standard Treatment |
Primary outcome
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease
Time frame: 1 Year
RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.
Change in Metabolic Tumor Volume 50% (MTV 50%)
Time frame: 2 months
The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model.
5 secondary outcomes
Patterns of Failure
Time frame: at 3 months and 2 years
Overall Survival
Time frame: at 3 months, and 2 Years
Progression- Free Survival
Time frame: at 3 months and 2 years
Incidence of Toxicity
Time frame: 1, 3 and 12 months
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Time frame: from Baseline up to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Michelle Mierzwa, M.D. principal investigator
University of Michigan Rogel Cancer Center
2 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 Carboplatin, Radiation Therapy and Paclitaxel in people with Oropharynx Cancer, run by University of Michigan Rogel Cancer Center 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 12 inclusion and 10 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: finished, as of the sponsor's last update on 7 Aug 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.
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?
Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 7 Aug 2026.