A Study of Reduced Radiation Therapy With 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 researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).

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.

T3-4/N0-2c or any N3 regardless of Tstage (AJCC 7th Edition) HPV+ OPC* or HPV associated squamous cell carcinoma with nodal metastasis (es) but unknown primary sites without evidence of distant metastasis based on FDG PET/CT.

Disqualifiers

Subjects with prior head and neck radiation therapy

Subjects with simultaneous primary cancers outside of 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

Trial design

Treatments tested in this trial

  • 18F-FMISO PET/CT Scan
  • Chemoradiation
  • Questionnaires

Treatment groups

74 Participants
are divided into 1 treatment group