Study on Reduced Intensity Chemoradiation After Robotic Surgery for HPV-Positive Throat Cancer

Sponsor: Cedars-Sinai Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04502407

Provider View

This clinical trial is exploring whether a less intense version of chemoradiation therapy, given after robotic surgery, can effectively treat HPV-positive throat cancer while causing fewer side effects. The study involves patients who have had or will need surgery to remove cancer before starting the treatment.

Patient Parameters

Program Overview

The study aims to find out if a reduced intensity of chemoradiation therapy, using cisplatin, can be as effective as the standard treatment for HPV-positive throat cancer, but with fewer side effects. It will include 40 patients who have had or will need surgery to remove visible cancer in the throat and lymph nodes. High-risk patients will receive a higher dose and longer treatment period than others.

Description

This trial is for patients with HPV-positive throat cancer who have had or will undergo robotic surgery to remove visible cancer in the throat and lymph nodes. A total of 36 patients at Cedars-Sinai Medical Center and its affiliates may participate. All eligible patients will receive a less intense version of cisplatin-based chemoradiation. High-risk patients will receive a higher dose and longer treatment period, lasting 3 to 5 weeks, depending on their risk level. The study will evaluate if this reduced treatment is as effective as the standard approach but with fewer side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of HPV-positive throat cancer, including tonsil and base of tongue cancer.
  • For unknown primary tumors, at least one metastatic lymph node must be present.
  • Cancer cells must show strong positivity for p16 in more than 70% of cells.
  • Must have had or will have surgery to remove all known cancer in the head and neck using robotic surgery.
  • Must have had or will have neck dissection surgery.
  • Must meet at least one of the following criteria after surgery:
    • Pathologic stage T3
    • 2 or more positive lymph nodes
    • At least one lymph node larger than 3 cm
    • Lymphovascular or perineural invasion
    • Extranodal extension
    • Close or positive surgical margins
  • Age 18 or older
  • Good overall health with an ECOG performance status of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must provide written informed consent and be able to comply with study requirements.
  • Adequate blood and kidney function as determined by specific tests.

Exclusion Criteria

  • Advanced cancer stage (pT4 or cN3) or evidence of cancer spread.
  • Recurrent cancer or inability to remove all cancer during surgery.
  • More than 56 days since surgery.
  • Previous radiation to the head and neck over 30 Gy.
  • Recent history of other active invasive cancers, except for certain low-risk types.
  • Severe health conditions, such as recent heart problems or infections.
  • Uncontrolled AIDS or severe hearing loss.
  • Active autoimmune diseases requiring immunosuppression.
  • Pregnant or breastfeeding women.
  • Allergic reaction to cisplatin.
  • Recent live vaccines before starting treatment.

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