Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT03875716 |
Recruitment Status :
Recruiting
First Posted : March 15, 2019
Last Update Posted : March 7, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Radiation: Radiation therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 111 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 20, 2019 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Low Risk
Observation without adjuvant therapy
|
Radiation: Radiation therapy
Radiation therapy |
Experimental: Intermediate Risk
Reduced-dose radiation (46Gy)
|
Radiation: Radiation therapy
Radiation therapy |
Experimental: High Risk
Postoperative radiation (60Gy) without chemotherapy
|
Radiation: Radiation therapy
Radiation therapy |
- Disease-free survival [ Time Frame: 2 years ]Survival without any signs or symptoms of cancer after the treatment ends.
- Overall Survival [ Time Frame: 2 years ]The length of time from the start of treatment until death.
- Toxicity Rate [ Time Frame: 2 years ]Adverse events experienced by the participants.
- 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).
- 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)
- 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)
- 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")
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875716
Contact: Danielle N. Margalit, MD, MPH | 617-632-6817 | dmargalit@lroc.harvard.edu |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02062 | |
Contact: Danielle N. Margalit, MD, MPH 617-632-3591 danielle_margalit@dfci.harvard.edu | |
Principal Investigator: Danielle N. Margalit, MD, MPH |
Principal Investigator: | Danielle N. Margalit, MD, MPH | Dana-Farber Cancer Institute |
Responsible Party: | Danielle Margalit, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03875716 |
Other Study ID Numbers: |
19-009 |
First Posted: | March 15, 2019 Key Record Dates |
Last Update Posted: | March 7, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Data can be shared no earlier than 1 year following the date of publication. |
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 |
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 |
Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site |