Overview
Study of Therapeutic Targets Tailored Ch and IMRT as Neoadjuvant Treatment in Rectal Carcinoma Patients
Status:
Completed
Completed
Trial end date:
2011-04-01
2011-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Grupo Hospital de MadridTreatments:
Oxaliplatin
Criteria
Inclusion Criteria:- Histologic diagnosis of rectal adenocarcinoma.
- Clinical stage II or III.
- Feasible patient for neoadjuvant Ch-RT.
- Availability of tumor tissue or possibility of a tumor biopsy to define therapeutic
targets.
- Informed written consent was obtained from all patients
Exclusion Criteria:
- Contraindication to the administration of any of the drugs used in the study
capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.