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New treatment option for Oropharyngeal Cancer
Official title Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT06445114
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for oropharyngeal cancer.
Also referred to as Chemoradiation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell...
- For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
- p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.
- Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with...
- Have undergone or will undergo neck dissection.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
- p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.
- Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral...
- 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
- Contralateral lymph node involvement
- 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.
- Patients consented preoperatively are required to have detectable cTTMV-HPV DNA based on pre-operative NavDx testing. For patients consented post-operatively, NavDx testing should be performed on the tumor tissue to...
- Age ≥ 18 years old
- ECOG performance status 0 or 2 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 56 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 ≥50 mL/min estimated using the following Cockcroft-Gault equation
- 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, stage T1aN0 kidney...
- 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 enrollment
- Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Tarzana, California, United States
- Torrance, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Los Angeles, California, United States; Tarzana, California, United States; Torrance, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.