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NCT06998342Toboroz2. fázis

MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer

MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 26.

Rövid összefoglaló (regiszter, angolul)

The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery. The main questions it aims to answer are: Does short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation? Researchers will compare: Short-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness. Active surveillance for moderate-risk patients to expected recurrence rates to assess safety. Participants will: High-Risk Group (SCRT): Receive short-course radiation therapy and attend follow-up visits. Moderate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence. Optionally provide blood samples for future biomarker research.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
24 (tervezett)
Első benyújtás
2025. máj. 7.
Kezdés
2025. jún. 4.
Elsődleges befejezés
2031. ápr.
Fő szponzor
University of Vermont Medical Center
NCT-szám
NCT06998342

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2. fázis
  • Tervezett résztvevők: 24
  • 2025. jún. 4. és az elsődleges befejezés (2031. ápr.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Patients receiving any other investigational agents.
    • Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
    • Serious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.
    • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable
    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    • Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.

Kiket keres a vizsgálat

  • Pathologically confirmed cutaneous squamous cell carcinoma of the head \& neck region, defined as extending from vertex of head to supraclavicular region.
  • Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration
  • Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup:
    • Clinical exam within 60 days prior to registration
    • CT head \& neck/soft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.
    • Bilateral neck ultrasound within 60 days prior to registration
  • Risk Factors fitting either the High-Risk or Moderate-Risk Categories:
    • Risk Factor Definitions
    • Major Risk Factors: Microscopic Extensive PNI (defined as PNI for \>3 nerves with all involved nerves either \>0.1 mm in size and/or deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \>6 cm, or Recurrent disease status post prior Mohs
    • Moderate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \>0.1 mm in size)
    • BWH Risk factors: \>2 cm, poor differentiation, deep invasion, PNI (\>0.1 mm in size)
  • BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors
    • High-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3
    • Moderate-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
University of Vermont Medical Center
Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát		BurlingtonEgyesült ÁllamokToboroz

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