Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Induction chemotherapy combined with Radio chemotherapy: Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during 14 days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1; repetition day 22 and 43 (3 cycles) Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy: Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m² bid, on each radiation day during the first 4 weeks of RCTx Surgery according to TME-criteria (total mesorectal excision) in compliance of an interruption of min. 14 days after RCTx
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria
Paracelsus Medical University Salzburg - Oncology
Salzburg, State of Salzburg, Austria
Medical University of Vienna, General Hospital
Vienna, State of Vienna, Austria
Medical University Graz, Oncology
Graz, Styria, Austria
termination of therapy
before surgery (after conclusion of therapy phase)
Time frame: up to 17 weeks
occurence of toxicity
until timepoint of discharge of patient
Time frame: up to 18-19 weeks
collection of response rate
T- and N-downstaging, pathological complete remission: measurement at the timepoint of surgery
Time frame: up to week 18
post-surgery morbidity
according to Accordion; measurement at the timepoint of discharge of patient
Time frame: after 18-19 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
State Hospital Feldkirch, Radiotherapy
Feldkirch, Vorarlberg, Austria