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Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence

Study acronym: SPINO-RT
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary and study completion dates: Jun 2029 to Jun 2031
    • Study sites: 22 to 28
    • Start date changed from estimate of Dec 2024 to Feb 21, 2025
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: 7 to 8
  2. Study description expanded, about 2 words
    • Study title shortened, about 5 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC). The investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC. The main question it aims to answer is: Is DFS different between the "adjuvant radiotherapy" group and the "surveillance" group? Participants will: * be distributed in one of the two arms * will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire) * followed up until their death or their progression whether local, regional or metastatic
Trial Details
NCT Number NCT06692556
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Cutaneous Squamous Cell Carcinoma (CSCC)
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov