Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria: i) histologically proven rectal adenocarcinoma (cT3-4N0-2 or cT2N1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria: i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.