Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Centre Hospitalier Universitaire Vaudois
OBJECTIVES: Primary * To determine the pathological complete response (CR) rate in resected patients assessed on lesions of less than or equal to 30 mm in size. Secondary * To determine the clinical CR rate in all patients. * To determine toxicity and tolerability of this regimen (pre- and postoperative toxicity). * To evaluate perioperative safety in these patients. * To determine disease-free survival (time to progression in unresected patients) and overall survival of the whole study population. * To determine resectability in these patients. * To evaluate markers that predict the occurrence of a pathological CR or a non-response in pathological material (resected liver metastasis) and biological material collected from these patients. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22, fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course 3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy. Patients undergo tumor tissue and blood sample collection periodically for biological studies. Samples are analyzed for markers that predict the occurrence of a complete pathological response (pCR) or a non-response. After completion of study treatment, patients are followed every 3 months for the first 2 years and then every 6 months thereafter.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
