Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT05800574
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oropharynx Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy (5 days for 7 weeks) — RADIATION
    Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)
  • Radiation therapy (5 days for 6 weeks) — RADIATION
    Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )
  • Cisplatin — DRUG
    Cisplatin, 40mg/m2 (weekly for 7 weeks)

Study Details

This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.

Key Dates

Start date
Mar 14, 2023
Status verified
May 2026
Primary completion
Sep 23, 2026
Completion
Sep 23, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (>N1 or single node > 3cm )
    More extensive neck involvement or proximity to the midline can qualify a patient in cohort A. Cohort A will have patients with either more than one lymph node adenopathy or 1 lymph node that is large (\>3cm).
  • Experimental: Cohort B (N0 or N1 <3cm)
    For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.

Primary Outcome Measure

Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Thomas Galloway, MD
[email protected]
215-728-4300

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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