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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

NCT06692556 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

RADIATION

Adjuvant radiotherapy

Patients will receive an adjuvant radiotherapy corresponding to an equivalent dose of 45 to 50 Gy (Equivalent Dose in 2 Gy Fractions \[EQD2\] with a tumor alpha/beta ratio of 10 Gy) delivered on the operating bed. Patients will be treated by : * either external radiation therapy using high-energy electrons or photons: * 45 Gy in 15 fractions of 3 Gy * 50 Gy in 25 fractions of 2 Gy * or interstitial brachytherapy or brachytherapy via skin applicators: * 36 Gy in 8 fractions of 4.5 Gy * 36 Gy in 9 fractions of 4 Gy * 40 Gy in 8 fractions of 5 Gy Radiation therapy should be started within 8 weeks after surgery (or 10 if delayed healing). Patients will be monitored regularly until the date of the first relapse (local, regional or metastatic), or until the date of death (if no relapse). Regardless of the type of relapse, remedial treatments will be left to the the investigator's discretion up to the first metastatic relapse.

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Mona AMINI-ADLE, Dr · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2031-06-30
Completion
2031-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06692556 on ClinicalTrials.gov