Description:
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.
Title
- Brief Title: Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
19-009
- NCT ID:
NCT03875716
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Low Risk | Experimental | Observation without adjuvant therapy
Pathologic T1-2, N0-1
Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck
-≤2 positive lymph nodes confined to level II and/or level III
No extranodal extension
Clear margins | |
Intermediate Risk | Experimental | Reduced-dose radiation (46Gy)
Pathologic T1-2N0-2 and any one of the following features:
->2 positive lymph nodes
<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 | |
High Risk | Experimental | Postoperative radiation (60Gy) without chemotherapy
Pathologic T1-4N0-2 and any one of the following features:
->1mm extranodal extension
Microscopic positive margins | |
Eligibility Criteria
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): 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease-free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Survival without any signs or symptoms of cancer after the treatment ends. |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The length of time from the start of treatment until death. |
Measure: | Toxicity Rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Adverse events experienced by the participants. |
Measure: | Quality Of Life Questionnaire |
Time Frame: | 2 Years |
Safety Issue: | |
Description: | 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). |
Measure: | Symptom burden: |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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) |
Measure: | Dysphagia |
Time Frame: | 2 Years |
Safety Issue: | |
Description: | 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) |
Measure: | Shoulder dysfunction |
Time Frame: | 2 Years |
Safety Issue: | |
Description: | 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") |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Dana-Farber Cancer Institute |
Last Updated
January 27, 2021