LCCC 1612: P53 mutational status and circulating free HPV DNA for the management of HPV-associated Oropharyngeal Squamous Cell Cancers

Purpose

The proposed study is a follow-up study to LCCC 1120 and 1413. The investigators have shown that de-intensification is efficacious in these two phase II studies. A major question is whether the investigators can de-intensify in patients with HPV-associated oropharyngeal cancer who have smoking histories. The investigators' hypothesis is that genomic profiling of patients' tumors (specifically for p53 mutations) will help in triaging patients to de-intensification versus standard of care.

Patients with HPV-associated OPSCC will be enrolled regardless of smoking history and p53 mutational status will be assessed in patients with a smoking history. The investigators will use the same de-intensification chemoradiotherapy regimen already evaluated in LCCC 1120 and 1413 in patients with HPV-associated OPSCC who have a minimal smoking history and in patients with a smoking history but with wild-type p53. Patients with a smoking history who have mutated p53 will not receive de-intensified chemoradiotherapy, but instead will receive standard doses.

The hypothesis is that by using genomics in the patients with a significant smoking history, the investigators will better select those who can be safely de-intensified. Circulating free HPV DNA (cf-HPV-DNA) will also be prospectively assessed from blood samples.

Eligibility

  • Ages 18 years old and older
  • T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
  • Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
  • 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 treatment, 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 pregnancy test within 2 weeks prior to treatment 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

Contact

For additional study information please reach out to John Lybarger:

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Oropharyngeal Squamous Cell Carcinoma, head and neck cancer, carcinoma, cancer, HPV

Principal Investigator

Robert J Amdur, M.D.

Sponsoring Group

Department of Radiation Oncology

Department

Department of Radiation Oncology

Contact Information

lybarj@shands.ufl.edu

352-265-0680 ext. 87829


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