- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875716
Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
March 5, 2024 updated by: Danielle Margalit, MD, MPH, Dana-Farber Cancer Institute
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Danielle N. Margalit, MD, MPH
- Phone Number: 617-632-6817
- Email: dmargalit@lroc.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02062
- Recruiting
- Dana Farber Cancer Institute
-
Contact:
- Danielle N. Margalit, MD, MPH
- Phone Number: 617-632-3591
- Email: danielle_margalit@dfci.harvard.edu
-
Principal Investigator:
- Danielle N. Margalit, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Risk
Postoperative radiation (60Gy) without chemotherapy
|
Radiation therapy
|
Experimental: Low Risk
Observation without adjuvant therapy
|
Radiation therapy
|
Experimental: Intermediate Risk
Reduced-dose radiation (46Gy)
|
Radiation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: 2 years
|
Survival without any signs or symptoms of cancer after the treatment ends.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 2 years
|
The length of time from the start of treatment until death.
|
2 years
|
Toxicity Rate
Time Frame: 2 years
|
Adverse events experienced by the participants.
|
2 years
|
Quality Of Life Questionnaire
Time Frame: 2 Years
|
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).
|
2 Years
|
Symptom burden:
Time Frame: 2 years
|
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)
|
2 years
|
Dysphagia
Time Frame: 2 Years
|
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)
|
2 Years
|
Shoulder dysfunction
Time Frame: 2 Years
|
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")
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle N. Margalit, MD, MPH, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2019
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication.
IPD Sharing Access Criteria
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org
or email TIDO@childrens.harvard.edu
BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
BWH - Contact the Partners Innovations team at http://www.partners.org/innovation
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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