Head and Neck CancerNCT03875716
Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
A study testing Radiation therapy in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 31 Dec 2029
- 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
- Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
- HPV-associated tumor as defined by: positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
- Eligible for curative-intent surgery with anticipated negative margins
- Surgery performed at Brigham \& Women's Hospital
- Age 18 or older years.
- ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
Show all 19Show fewer
- Normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,000/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine ≤ 1.5 times the institutional upper limit of normal OR
- creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20 cigarettes.
- Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2
- Nodal clinical stage (AJCC 8th edition): N0 or N1
- No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior history of head and neck cancer within 5 years.
- Prior head and neck radiation
- Clinically fixed or matted nodes
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: that HIV positive patients will be eligible.
- Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02062
Danielle N. Margalit, MD, MPH, 617-632-3591, danielle_margalit@dfci.harvard.edu
Danielle N. Margalit, MD, MPH
About this study
Official title: A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma: the ADAPT Trial
This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.
Read the detailed description
This research study is being done to study if less intensive treatments can be used after surgery for head and neck cancers that are due to the human papilloma virus (HPV). In general, these cancers have better cure rates than other types of head and neck cancers. Therefore, the investigators are studying whether we can safely reduce the amount of treatment after surgery, such as surveillance (instead of using radiation) or less radiation or less chemotherapy, while maintaining good cure rates. The investigators hope that by reducing the intensity of treatment, this will lead to less side effects during and after cancer treatment.
- Conditions
- Head and Neck Cancer
- Being tested
- Radiation therapy
- Keywords
- radiation de-intensification
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | Experimental | Observation without adjuvant therapy
* Pathologic T0-2, N0-1
* Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck
* Single positive lymph node up to 3cm
* No extranodal extension
* Clear margins
* Undetectable postoperative circulating tumor HPV DNA Receives: Radiation: Radiation therapy |
| Intermediate Risk | Experimental | Reduced-dose radiation (46Gy)
* Pathologic T0-2N0-2 and any one of the following features:
* 2 or more positive lymph nodes
* single node >3cm
* <15 lymph nodes retrieved on neck dissection for each side of the neck
* Positive lymph nodes in level IB, IV, or V
-≤1mm extranodal extension
* Positive lymph node(s) contralateral to the primary tumor
* Close margins
* Detectable postoperative circulating tumor HPV DNA Receives: Radiation: Radiation therapy |
| High Risk | Experimental | Postoperative radiation (60Gy) without chemotherapy
* Pathologic T0-4N0-2 and any one of the following features:
->1mm extranodal extension
* Microscopic positive margins Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Survival without any signs or symptoms of cancer after the treatment ends.
Measured: 2 years
Secondary outcomes (6)
Overall Survival
The length of time from the start of treatment until death.
Measured: 2 years
Toxicity Rate
Adverse events experienced by the participants.
Measured: 2 years
Quality Of Life Questionnaire
Assesses the physical; social/family; emotional and functional wellbeing, using Functional Assessment of Cancer Therapy for Head and Neck (FACT-H\&N) on a scale of 0-4 (where 0 indicates the lowest quality of life and 4 indicates the highest quality of life).
Measured: 2 Years
Symptom burden:
Patient-reported symptom severity, using M.D. Anderson Symptom Inventory - Head \& Neck (MDASI-HN) on a scale of 0-10 (where 0 indicates symptom is not present and 10 indicates the symptom is as bad as can be)
Measured: 2 years
Dysphagia
Swallowing ability or difficulty. Dysphagia-related quality of life, assessed with the MD Anderson Dysphagia Inventory (MDADI) on a scale of 1-5 (where 1 indicates the patient strongly agrees and 5 indicates the patient strongly disagrees)
Measured: 2 Years
Shoulder dysfunction
Shoulder function or dysfunction is measured with the "neck dissection impairment index" (NDII). This evaluates how much the patient's neck and/or shoulder affects them as a result of the treatment they received in their neck during the overall management of their cancer. This scale goes from 1-5 (1 being "not at all" and 5 being "a lot")
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 posted15 Mar 2019
- Study start20 May 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (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.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Margalit, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Danielle N. Margalit, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875716
- Sponsor's protocol ID
- 19-009
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma: the ADAPT Trial
- ClinicalTrials.gov ID
- NCT03875716
- Acronym / sponsor ID
- 19-009
- Conditions
- Head and Neck Cancer
- Keywords
- radiation de-intensification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Mar 2019 (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 research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.
Detailed description
This research study is being done to study if less intensive treatments can be used after surgery for head and neck cancers that are due to the human papilloma virus (HPV). In general, these cancers have better cure rates than other types of head and neck cancers. Therefore, the investigators are studying whether we can safely reduce the amount of treatment after surgery, such as surveillance (instead of using radiation) or less radiation or less chemotherapy, while maintaining good cure rates. The investigators hope that by reducing the intensity of treatment, this will lead to less side effects during and after cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Risk | Experimental | Radiation: Radiation therapyObservation without adjuvant therapy * Pathologic T0-2, N0-1 * Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck * Single positive lymph node up to 3cm * No extranodal extension * Clear margins * Undetectable postoperative circulating tumor HPV DNA |
| Intermediate Risk | Experimental | Radiation: Radiation therapyReduced-dose radiation (46Gy) * Pathologic T0-2N0-2 and any one of the following features: * 2 or more positive lymph nodes * single node >3cm * <15 lymph nodes retrieved on neck dissection for each side of the neck * Positive lymph nodes in level IB, IV, or V -≤1mm extranodal extension * Positive lymph node(s) contralateral to the primary tumor * Close margins * Detectable postoperative circulating tumor HPV DNA |
| High Risk | Experimental | Radiation: Radiation therapyPostoperative radiation (60Gy) without chemotherapy * Pathologic T0-4N0-2 and any one of the following features: ->1mm extranodal extension * Microscopic positive margins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
- HPV-associated tumor as defined by: positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
- Eligible for curative-intent surgery with anticipated negative margins
- Surgery performed at Brigham \& Women's Hospital
- Age 18 or older years.
Key exclusion criteria (5 listed)
- Prior history of head and neck cancer within 5 years.
- Prior head and neck radiation
- Clinically fixed or matted nodes
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: that HIV positive patients will be eligible.
- Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
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 |
|---|---|---|
| Radiation therapyRadiation therapy | Radiation | High Risk, Intermediate Risk, Low Risk |
Primary outcome
Disease-free survival
Time frame: 2 years
Survival without any signs or symptoms of cancer after the treatment ends.
6 secondary outcomes
Overall Survival
Time frame: 2 years
Toxicity Rate
Time frame: 2 years
Quality Of Life Questionnaire
Time frame: 2 Years
Symptom burden:
Time frame: 2 years
Dysphagia
Time frame: 2 Years
Shoulder dysfunction
Time frame: 2 Years
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 13 Mar 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Danielle N. Margalit, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute 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 19 inclusion and 5 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 13 Mar 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.
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 Danielle N. Margalit, MD, MPH (617-632-3591, danielle_margalit@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (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 13 Mar 2026.