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New treatment option for Oropharynx Cancer
Official title De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
ClinicalTrials.gov ID: NCT06554158
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are: Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Patients must be ≥ 18 years of age on the day of signing informed consent.
- Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus...
- pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved...
- Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.
- neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
You likely can't join if
- Perineural invasion at primary site
- Lymphovascular space invasion at primary site
- Level 4 nodal involvement (even if resected)
- Retropharyngeal nodal involvement (even if resected)
- any intact, unresected disease
- nodal disease pathologically invading adjacent neck musculature
See the full eligibility criteria
- Patients must be ≥ 18 years of age on the day of signing informed consent.
- Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).
- pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins...
- Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.
- neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
- hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
- current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
- start radiation within 8 weeks of resection (6 weeks preferable)
- have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days...
- Ability to understand and willingness to sign a written informed consent.
- Perineural invasion at primary site
- Lymphovascular space invasion at primary site
- Level 4 nodal involvement (even if resected)
- Retropharyngeal nodal involvement (even if resected)
- any intact, unresected disease
- nodal disease pathologically invading adjacent neck musculature
- Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy
- Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate...
- Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, 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.