Status:
WITHDRAWN
RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Human Papillomavirus (HPV)
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine the rate of local regional control at 2 years when using de-intensified chemoradiotherapy (CRT) in patients with Human Papillomavirus (HPV)-associate...
Detailed Description
The purpose of this research study is to determine the rate of local regional control at 2 years when using de-intensified chemoradiotherapy (CRT) in patients with Human Papillomavirus (HPV)-associate...
Eligibility Criteria
Inclusion
- Patients must meet the following inclusion criteria to be eligible for enrollment in RBD-HPV:
- Histologically-confirmed squamous cell carcinoma of the head and neck, including subsites of the oropharynx, hypopharynx, larynx, and nasopharynx (with data on EBV)
- P16+ positivity as measured by IHC in a lab that is verified by the central laboratory or if the slides are available for review by the central laboratory
- HPV positivity by PCR assessed with either tissue or cytology in the central laboratory
- Stages I, II, III, or IV according to the AJCC 7th edition without evidence of distant metastases
- Age \> 18
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate marrow function as defined by the following parameters:
- Neutrophil count \> 1.5 x 109/l
- Platelet count \> 100 x 109/l
- Hemoglobin \> 10 g/dl
- Adequate renal function as defined by a creatinine clearance \> 60 ml/min (actual or calculated by the Cockcroft-Gault equation)
- Adequate liver function as defined by the following parameters:
- Total bilirubin \< institutional upper limit of normal (ULN) (except patients with Gilbert's Syndrome who have no other liver disease or abnormal liver serologies)
- AST or ALT and alkaline phosphatase within the ranges described below
- A negative pregnancy test within 7 days of starting therapy in women of childbearing potential
- Capacity to understand the study protocol
- Willingness to provide written consent.
Exclusion
- Patients will not be eligible for enrollment in this study if they exhibit any of the following conditions:
- Women who are currently pregnant or breast-feeding
- Men or women of childbearing potential who are not using adequate contraception during treatment and at least 3 months after therapy
- Current or prior malignancy in the last 5 years (excluding basal or squamous cell carcinoma of the skin not requiring systemic or radiation therapies, or prostate CA that is well-controlled and observed, etc)
- Radiation therapy for prior malignancy (except radioactive iodine for thyroid cancer)
- Prior chemotherapy for other malignancy or autoimmune disease
- Metastatic disease at presentation
- Nasal cavity subsite
- Active smoking (defined as \> 1 cigarette per day within the last five years) or former smoking (has to have quit \> 10 years ago) with a cumulative pack year history \> 40 pack years
- Prior radiation therapy or chemotherapy for HNSCC (prior surgery alone is permitted)
- Active substance use disorder (ETOH or drugs, excluding marijuana)
- Prior use of IV drugs
- Significant peripheral neuropathy (\> grade 2 according to NCI CTC)
- Prior hematologic or solid organ transplant
- Major medical comorbidity including:
- Significant cardiovascular disease.
- Significant neurologic disorder, including dementia and seizures.
- Significant psychiatric disorder.
- Active infection that is uncontrolled.
- PUD (peptic ulcer disease) that is clinically active or unhealed.
- Hypercalcemia.
- COPD with hospitalization in the last 12 months for pneumonia or respiratory failure.
- Interstitial lung disease.
- Autoimmune disease requiring therapy.
- Uncontrolled HIV infection (not on HAART, CD4 \< 200).
- Active Hepatitis C (+ RNA).
- Enrollment in a therapeutic clinical trial within 30 days of study entry
- Concurrent treatment with any other antineoplastic therapy
- Significant weight loss (\> 25% of TBW) in the 2 months prior to study entry
- Patient has a history of non-adherence to medical care
- Patient will not be able to engage in comprehensive follow-up at Mount Sinai.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04849377
Start Date
June 14 2022
End Date
June 14 2022
Last Update
July 7 2022
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029