303
Participants
Start Date
October 17, 2023
Primary Completion Date
March 1, 2028
Study Completion Date
March 1, 2028
Surgery with additional moderate hypofractionation RT (15 fractions)
"After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).~Adjuvant Radiotherapy:~-Arm B: Surgery followed by moderate hypofractionation RT (15 fractions): 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed."
Surgery alone, without radiation post surgery
Arm A: Surgery alone followed by surveillance
Surgery with extreme hypo fractionation treatment (HF)
"After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).~Adjuvant Radiotherapy:~-Arm C= Surgery followed by extreme hypofractionation RT (5 fractions, 2 fractions/week): 30Gy in 5 fractions of 6Gy over 5 weeks to the operative bed."
RECRUITING
Henri Mondor, Créteil
Assistance Publique - Hôpitaux de Paris
OTHER