Status:
COMPLETED
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or ...
Detailed Description
The proposed study is a follow-up study to NCT01530997. In NCT01530997, patients with HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) received de-intensified ch...
Eligibility Criteria
Inclusion
- ≥ 18 years of age (no upper age limit)
- T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
- Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
- ≤ 10 pack-years smoking history or ≤ 30 pack-years smoking history WITH ≥ 5 years abstinence from smoking
- Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment
- ECOG Performance Status 0-1
- CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows: Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.
- Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine \< 2.0 mg/dl; Total bilirubin \< 2 x the institutional ULN; AST or ALT \< 3 x the institutional ULN.
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide study specific informed consent prior to study entry
Exclusion
- Prior history of radiation therapy to the head and neck
- Prior history of head and neck cancer.
- Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves)
- Currently taking Disease Modifying Rheumatoid Drugs (DMRDs)
- Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note, however, coagulation parameters are not required for entry into this protocol); Pre-existing ≥ grade 2 neuropathy; Prior organ transplant; Systemic lupus; Psoriatic arthritis.
- Known HIV positive.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2024
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT02281955
Start Date
August 1 2014
End Date
November 24 2024
Last Update
January 7 2025
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599
3
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
4
High Point Regional Health
High Point, North Carolina, United States, 27262