Clinical Trial

Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

Study acronym: SANTAL
Active, Not Recruiting Phase 3
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Summary
A phase III, multicenter, randomized, open-label, french study comparing: * Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy) * Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2016-12-16; most recent amendment 2025-05-06.
Status change: Recruiting → Active, Not Recruiting 2025-05-06
Trial Details
NCT Number NCT02998385
Lead Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Collaborators: National Cancer Institute, France
Conditions HNSCC
Enrollment 342 participants
Start Date 2017-01-20
Primary Completion 2030-02 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2025-05-07