De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study

Completed · Phase 2

Conditions studied: Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms

In brief

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 unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, \> 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.

Key facts

Study ID

NCT02281955

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

115

Starts

2014-08-01

Expected to finish

2024-11-24

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States
• Pardee Memorial Hospital — Hendersonville, North Carolina, United States
• High Point Regional Health — High Point, North Carolina, United States
• Rex Healthcare — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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