drugset / Trial / NCT01366118
Study of Therapeutic Targets Tailored Ch and IMRT as Neoadjuvant Treatment in Rectal Carcinoma Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The parameter that best correlates with 5 years disease-free survival (DFS ) in patients (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after chemo-radiotherapy (Ch-RT). DFS is 97% in pts with ypT0N0M0 = ypCR and 42% in pts with ypN +. Standard 5-FU Ch-RT achieves 15% of ypCR. The use of IMRT achieves a high proportion of ypCR . This study aimed to demonstrate in a prospective manner the feasibility of personalizing Ch regimen base in TT in combination with IMRT in patients with RC. Secondary objectives included the number of ypCR and safety.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-04
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 825 mg/m2 | — |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 50 g | — |