Status:
RECRUITING
De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
MedStar Georgetown University Hospital
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, wh...
Detailed Description
HPV+ oropharyngeal carcinoma can be treated with either definitive radiotherapy or transoral surgery (TOS, using a predominantly robotic or laser approach), with equivalent oncologic results.23 The pr...
Eligibility Criteria
Inclusion
- 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 at primary site.
- 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 following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and willingness to sign a written informed consent.
Exclusion
- 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 cancer that is undergoing active surveillance.
- Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06554158
Start Date
August 1 2019
End Date
December 31 2028
Last Update
March 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007