De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca

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 followed by a limited surgical evaluation.

Key facts

Study ID

NCT01530997

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

45

Starts

2012-02-07

Expected to finish

2019-11-01

Last updated by the study team

2024-11-13

Who can join

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

You may qualify if…

• ≥ 18 years of age
• 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 > 5 years of abstinence from smoking
• History/physical examination within 8 weeks prior to registration
• Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration.
• The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; 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 upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (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.
• 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.
• Known HIV positive
• Significant pre-existing hearing loss, as defined by the patient or treating physician.

Where it is running

• Penrose Cancer Center — Colorado Springs, Colorado, United States
• University of Florida, Department of Radiation Oncology — Gainesville, Florida, United States
• University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States
• Rex Healthcare — Raleigh, North Carolina, United States
• Rex Cancer Center of Wakefield — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.