Status:
ACTIVE_NOT_RECRUITING
Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will enroll patients with HPV-associated oropharyngeal cancer, undergoing resection of all gross visible disease at the primary site and in the lymph nodes. A total of 40 patients who have ...
Detailed Description
This is a single arm phase II study that will enroll patients with HPV-associated oropharyngeal cancer, undergoing resection through trans-oral robotic surgery (TORS) of all gross visible disease at t...
Eligibility Criteria
Inclusion
- AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.
- For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
- p16 should be strongly and diffusely positive in the nuclear and cytoplasmic component in greater than 70% of the tumor cells.
- Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with unknown primary tumors, a minimum of an ipsilateral tonsillectomy and base of tongue resection is required.
- Have undergone or will undergo neck dissection.
- Have at least one of the following after surgery:
- Pathologic stage T3
- 2 or more positive lymph nodes
- At least one lymph node \>3cm
- Lymphovascular invasion
- Perineural invasion
- Extranodal extension
- Close/positive margins: Close margins are considered \<3mm from the peripheral margins and \<1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.
- Age ≥ 18 years old
- ECOG performance status 0 or 1 within 56 days of start of chemoradiation.
- Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Adequate hematologic and renal function within 30 days of start of chemoradiation, defined as:
- Hemoglobin ≥ 9.0 g/dL
- Platelets ≥ 100, 000 cells/mm3
- ANC ≥ 1.5 X 109/L
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase/alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN)
- Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥60 mL/min
Exclusion
- AJCC 8th edition pT4 or cN3 disease.
- Radiologic or clinical evidence of distant metastasis.
- Recurrent disease.
- Inability to achieve gross total resection at time of surgery.
- Greater than 56 days (8 weeks) after surgical resection of the primary site.
- Prior radiation to the head and neck \> 30 Gy.
- Prior active invasive (not in situ) malignancy within the prior 2 years, excluding cutaneous basal cell or squamous cell carcinoma, low or intermediate risk prostate cancer, papillary thyroid cancer, AJCC 8th edition stage I-II breast cancer, or low grade non-Hodgkin lymphoma
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects
- Uncontrolled Acquired Immune Deficiency Syndrome (AIDS), defined as a CD4 count \< 200 at screening or an AIDS-defining opportunistic infection within the last 6 months.
- Moderate to severe hearing loss.
- Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression.
- Pregnant or breast-feeding women.
- Prior allergic reaction to cisplatin.
- Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04502407
Start Date
February 16 2021
End Date
December 15 2029
Last Update
September 9 2025
Active Locations (4)
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1
Tower Hematology-Oncology
Beverly Hills, California, United States, 90211
2
Cedars-Sinai Medical Center (Beverly - Main Site)
Los Angeles, California, United States, 90048
3
Valley Oncology Medical Group
Tarzana, California, United States, 91356
4
Torrance Memorial Physician Network Cancer Care
Torrance, California, United States, 90505