P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
LCCC 1612: P53 Mutational Status and Circulating Free HPV DNA for the Management of HPV-associated Oropharyngeal Squamous Cell Cancers
1 other identifier
interventional
195
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2022
CompletedResults Posted
Study results publicly available
May 2, 2024
CompletedMay 2, 2024
April 1, 2024
6 years
January 30, 2017
November 6, 2023
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up.
Two years after completion of the treatment
Secondary Outcomes (9)
Number of Participants With Plasma Circulating Free DNA -Baseline
Baseline
Number of Participants With Plasma Circulating Free DNA -3months
3 months after completion of the treatment
Number of Participants With Plasma Circulating Free DNA -1 Year
1 year after completion of the treatment
Number of Participants With Plasma Circulating Free DNA -2 Year
2 years after completion of the treatment
Local Control Rate
2 years after completion of the treatment
- +4 more secondary outcomes
Study Arms (1)
Radiotherapy and/or chemotherapy.
EXPERIMENTALSubjects with Oropharyngeal Squamous Cell Carcinoma receiving radiotherapy and/or chemotherapy.
Interventions
60- 70 Gy at 2 Gy/fx
The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 -7 total doses.
Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.
Eligibility Criteria
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
- 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
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Florida
Gainesville, Florida, 32610, United States
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206, United States
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Related Publications (1)
Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4.
PMID: 32017652DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included in the data tables.
Results Point of Contact
- Title
- Melahat G. Canter MD MS Clinical Trial Analyst
- Organization
- University of North Carolina Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Wendell Gray Yarbrough, MD
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
March 10, 2017
Study Start
December 1, 2016
Primary Completion
December 14, 2022
Study Completion
December 14, 2022
Last Updated
May 2, 2024
Results First Posted
May 2, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share