A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

Qualifiers

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.

Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI

Patient must have excisional biopsy or core biopsy done in order to be on protocol

Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.

Disqualifiers

Subjects with prior head and neck radiation therapy

Subjects with simultaneous primary cancers outside of the oropharynx

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

Trial design

Treatments tested in this trial

  • 18 F-FMISO PET/CT
  • Radiation
  • Cisplatin
  • Carboplatin
  • 5-fluorouracil

Treatment groups

121 Participants
are divided into 4 treatment groups