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Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer

NCT04572100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ari Rosenberg · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-01-09
Completion
2023-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572100 on ClinicalTrials.gov