Clinical Trial: P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers

Brief Summary: The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with > 10 pack years smoking history. Hypothesis: Patients with HPV-associated OPSCC, > 10 pack years smoking history, and non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with < 10 pack years smoking history.

Detailed Summary: 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.
Sponsor: UNC Lineberger Comprehensive Cancer Center

Current Primary Outcome: 2 year Progression Free Survival after de-intensified chemoradiation therapy (CRT) in HPV-associated OPSCC [ Time Frame: Two years after completion of CRT on last enrolled patient ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in plasma circulating free HPV DNA during and after treatment as related to clinical outcomes in patients with HPV-associated OPSCC [ Time Frame: Two years after completion of CRT on last enrolled patient ]
  • Local control rate [ Time Frame: 2 years post-CRT ]
  • Regional control rate [ Time Frame: 2 years post-CRT ]
  • Local-regional control rate [ Time Frame: 2 years post-CRT ]
  • Distant metastasis free survival [ Time Frame: 2 years post-CRT ]
  • Overall survival rate [ Time Frame: 2 years post-CRT ]
  • Head and neck quality of life assessments [ Time Frame: From date of study enrollment to last follow-up as long as patient continues seeing study doctor, up to 30 years ]
  • Speech and swallowing function via penetration-aspiration scale (PAS) and EAT-10 survey assessments [ Time Frame: From date of study enrollment to last follow-up as long as patient continues seeing study doctor, up to 30 years ]


Original Secondary Outcome: Same as current

Information By: UNC Lineberger Comprehensive Cancer Center

Dates:
Date Received: January 30, 2017
Date Started: August 2016
Date Completion: August 2046
Last Updated: March 6, 2017
Last Verified: March 2017