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Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms

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Trial Information

Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma

The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive
low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified
chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated
Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic
imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess
response. All patients will have surgical resection of any clinically apparent residual
primary tumor or biopsy of the primary site if there is no evidence of residual tumor and
will undergo a limited neck dissection to encompass at least those nodal level(s) that were
positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the
rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality
of life and patient reported outcomes will be obtained prior to, during, and after CRT.

Inclusion Criteria:

1. ≥ 18 years of age

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. ≤ 10 pack-years smoking history or > 5 years of abstinence from smoking

5. History/physical examination within 8 weeks prior to registration

6. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks
prior to registration.

7. ECOG Performance Status 0-1

8. 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.

9. 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 ULN;
AST or ALT < 3 x the institutional ULN.

10. Negative serum pregnancy test within 2 weeks prior to registration for women of
childbearing potential.

11. Women of childbearing potential and male participants who are sexually active must
practice adequate contraception during treatment and for 6 weeks following treatment.

12. Patients must be deemed able to comply with the treatment plan and follow-up

13. 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. 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.

4. Known HIV positive

5. Significant pre-existing hearing loss, as defined by the patient or treating

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathological response rate after de-escalated CRT in HPV-positive and/or p16 positive OPSCC.

Outcome Time Frame:

6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened

Safety Issue:


Principal Investigator

Bhishamjit Chera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

January 2016

Related Keywords:

  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Human Papilloma Virus
  • Oropharynx
  • Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma
  • Radiation Therapy
  • Chemotherapy
  • p16
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms



Rex HealthcareRaleigh, North Carolina  27607
University of Florida, Department of Radiation OncologyGainesville, Florida  32610-0385
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North Carolina  27599
Rex Cancer Center of WakefieldRaleigh, North Carolina  27614