Study of Therapeutic Targets Tailored Ch and IMRT as Neoadjuvant Treatment in Rectal Carcinoma Patients
TT
Prospective Pilot Study of Therapeutic Targets (TT) Tailored Chemotherapy (Ch) and Intensity Modulated Radiotherapy (IMRT) as Neoadjuvant Treatment in Patients With Rectal Carcinoma
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedJune 3, 2011
October 1, 2009
1.5 years
May 31, 2011
June 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ypTN
pathology TN after neoadjuvant treatment and surgery
Up to 1 month
Secondary Outcomes (1)
Feasibility
Up to 3 months
Study Arms (1)
TT tailored Ch plus IMRT
EXPERIMENTALInterventions
All pts were treated with Capecitabine (Cap) 625-825 mg/m2/12h M-F. Ch combination schema was customized based on: Top- 1 +: Irinotecan (I) 50mg/m2 / in weekly. Top-1 - and ERCC-1 - : Oxaliplatin (O) 50gm/m2/ weekly. Top- 1 - and ERCC-1 + : Neither I nor O. K-Ras or b-Raf mutated (m) : Bevacizumab (B) 5mg/kg every two weeks. K-Ras and B-Raf native (n): Cetuximab (C) 400/250mg/m2 weekly or B (investigator option). Figure 1. When Cap was in combination with O or I the 625mg/m2 dose was chosen. When Cap was the only chemotherapy agent in combination with B or C the 825mg/m2 dose was chosen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication to the administration of any of the drugs used in the study capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Integral Oncológico Clara Campal
Madrid, Madrid, 28050, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Cubillo, MD.PhD
Centro Integral Oncológico Clara Campal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 3, 2011
Study Start
October 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 3, 2011
Record last verified: 2009-10