Status and phase
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About
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).
Enrollment
Sex
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Volunteers
Inclusion criteria
Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status.
Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.
Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
ECOG Performance Status of 0-2 or KPS ≥ 50
Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).
Adequate hematologic function within 30 days prior to registration, defined as follows:
Adequate renal function within 30 days prior to registration, defined as follows:
Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).
Adequate hepatic function within 30 days prior to registration, defined as follows:
Note: Exceptions can be made with PI and/or Co-Pi approval for patients to enroll on trial with a higher Bilirubin level such as Gilbert's Syndrome.
Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).
Exclusion criteria
Subjects with prior head and neck radiation therapy
Subjects with simultaneous primary cancers outside of the oropharynx
a. Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Severe, active co-morbidity defined as follows: (exceptions can be made if approved by the PI and/or co-PI)
Primary purpose
Allocation
Interventional model
Masking
121 participants in 4 patient groups
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Central trial contact
Nancy Lee, MD; Heiko Schoder, MD
Data sourced from clinicaltrials.gov
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