Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• • Locally recurrent rectal cancer.
‣ Bioptically verified (adenocarcinoma )
⁃ Available dose plan from primary radiotherapy
⁃ Previous pelvic RT (\>30Gy EQD2)
⁃ Evaluated in MDT-conferences (Herlev, Aarhus)
⁃ Age\>18 years
⁃ PS 0-2
⁃ Adequate organ function
⁃ Informed consent
Locations
Other Locations
Denmark
Danish Centre for Particle Therapy
RECRUITING
Aarhus
Contact Information
Primary
Camilla Kronborg, MD, PhD
camkro@rm.dk
+45 78450000
Time Frame
Start Date: 2020-10-10
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 65
Treatments
Experimental: Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily
Experimental: Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus