Protocol Summary

Protocol No.: OCR17049

Sponsor Protocol No.: LCCC1612

Protocol Title: P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC

Principal Investigator: Dagan, Roi

Objective: 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

Description: Assessment for surgical evaluation 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.

Phase: Phase II

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: Local

Treatment:
Experimental:
Intensity Modulated Radiotherapy (IMRT) - deintensified
60 Gy at 2 Gy/fx
Cisplatin (or alternative) - deintensified
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 total doses.
Comparator:
Intensity Modulated Radiotherapy (IMRT) - standard
70 Gy at 2 Gy/fx
Cisplatin (or alternative) - standard
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, 7 total doses.

Detailed Eligibility:
INCLUSION CRITERIA:
1. Ages 18 years or older
2. T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
3. Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
4. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment
5. ECOG Performance Status 0-1
6. 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
7. Adequate renal and hepatic function within 4 weeks prior to treatment, defined as follows: Serum creatinine 8. Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
9. Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
10. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
11. Patients must provide study specific informed consent prior to study entry
EXCLUSION CRITERIA:
1. Prior history of radiation therapy to the head and neck
2. Prior history of head and neck cancer.
3. Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves)
4. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs)
5. 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
6. Known HIV positive.

Applicable Conditions:

  • Head & Neck Cancer
  • Participation Institution:

  • UF Gainesville : Catherine Anderson
  • UF Jacksonville : Catherine Anderson
  • Contact:
    Catherine Anderson, BS, RN
    Phone: +1 904-588-1443
    Email: canderson@floridaproton.org

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03077243