NCT04572100

Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer

Pilot Study of Induction Chemotherapy Followed by Risk and Response-Stratified Treatment for Locoregional HPV Associated Oropharyngeal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Doctors leading this study will give blood tests to head and neck cancer participants during the beginning of chemotherapy treatment (also known as induction therapy) to see if these blood tests can help predict tumor shrinkage after therapy and reduce the amount of additional radiotherapy or chemotherapy treatment the participant may need. This study will also examine ways to reduce overall side effects of treatment using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone.

Conditions

• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Transoral Robotic Surgery (TORS) or Radiotherapy	Participants assigned to this group will receive transoral robotic surgery (TORs) or radiotherapy. Radiotherapy is given once a day for 5 weeks. A percentage of subjects who undergo surgery may need further radiotherapy with or without chemotherapy based on the results of the surgery. TORs is surgery in which a robot with arms is used to remove cancer from hard-to-reach areas of the mouth and throat.
OTHER	Chemotherapy and Low-Dose Radiotherapy	Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
OTHER	Chemotherapy and High-Dose Radiotherapy	Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
DRUG	Paclitaxel	This drug will be combined with carboplatin during induction therapy for 9 weeks.
DRUG	Carboplatin	This drug will be combined with paclitaxel during induction therapy for 9 weeks.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2020-10-01
• Last updated: 2023-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study