Intensity-Modulated Radiation Therapy and Chemotherapy in Treating Patients with Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and overLCCC 1413
NCI-2014-02348, 14-1795, NCT02281955

Trial Description

Summary

This phase II trial studies how well intensity-modulated radiation therapy (IMRT) and chemotherapy work in treating patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma. Drugs used in chemotherapy, such as cisplatin, cetuximab, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy delivers thin beams of radiation of different intensities aimed at the tumor from many angles and may reduce the damage to healthy tissue near the tumor. Giving IMRT with chemotherapy may kill more tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate 2 year progression free survival (PFS) after de-intensified chemoradiotherapy (CRT) in HPV-positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC).

SECONDARY OBJECTIVES:

I. To assess the 2 year clinical outcomes of local control (LC), regional control (RC), local-regional control (LRC), distant metastasis free survival (DMFS), and overall survival (OS).

II. To compare head and neck quality of life assessments before, during, and after CRT.

III. To compare speech and swallowing function before and after CRT.

OUTLINE:

Patients undergo IMRT five days a week for 6 weeks. Patients without T0-2 N0-1 disease and > 10 pack years smoking history also receive either cisplatin intravenously (IV); cetuximab IV; carboplatin IV and paclitaxel IV; or carboplatin IV on days 1, 8, 15, 22, 29, and 36 during IMRT. Patients with positive positron emission tomography (PET)/computed tomography (CT) at 10-16 weeks may undergo biopsy and/or surgical resection of the tumor and lymph node metastases at the discretion of the surgeon.

After completion of study treatment, patients are followed up every 2 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Eligibility Criteria

Inclusion Criteria:

T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx

Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive

=< 10 pack-years smoking history or =< 30 pack-years smoking history WITH >= 5 years abstinence from smoking

Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, chest x-ray is required; CT imaging of the chest or PET/CT is acceptable

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Platelets >= 100,000 cells/mm^3

Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

Serum creatinine < 2.0 mg/dl

Total bilirubin < 2 x the institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN

Negative serum pregnancy test within 2 weeks prior to registration 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

Exclusion Criteria:

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)

Extensive history of using smokeless tobacco products or marijuana defined as daily use >= 5 years

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

Known human immunodeficiency virus (HIV) positive

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Lineberger Comprehensive Cancer Center

  • National Cancer Institute
Bhisham Chera, Principal Investigator

Trial Sites

U.S.A.

Florida
Gainesville

University of Florida

Robert Jess Amdur
Ph: 352-265-0287
Email: amdurr@shands.ufl.edu

Robert Jess Amdur
Principal Investigator

North Carolina
Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Bhisham Chera
Ph: 919-966-7700
Email: bchera@med.unc.edu

Bhisham Chera
Principal Investigator

Hendersonville

Margaret R Pardee Memorial Hospital

William Mark McCollough
Ph: 828-696-1330
Email: Mark.McCollough@pardeehospital.org

William Mark McCollough
Principal Investigator

High Point

High Point Regional Hospital

Mohit Sourabh Kasibhatla
Ph: 336-878-6036
Email: mkasibhatla@hprhs.com

Mohit Sourabh Kasibhatla
Principal Investigator

Raleigh

Rex Cancer Center

Nathan Christopher Sheets
Ph: 919-784-1251
Email: nathan.sheets@rexhealth.com

Nathan Christopher Sheets
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02281955

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.