XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Ra... | NCT00557713 | Trialant
NCT00557713
Sponsor
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Status
Unknown status
Last Update Posted
Nov 14, 2007Estimated
Enrollment
44Estimated
Phase
Phase 2
Conditions
Rectal Neoplasms
Locally Advanced Rectal Adenocarcinoma
Interventions
bevacizumab
Countries
Spain
Protocol Section
Identification Module
NCT ID
NCT00557713
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AVACROSS
Secondary IDs
Not provided
Brief Title
XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Official Title
Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study
Acronym
Not provided
Organization
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socialsOTHER
Status Module
Record Verification Date
Nov 2007
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2007
Primary Completion Date
Not provided
Completion Date
Oct 2013Estimated
First Submitted Date
Nov 13, 2007
First Submission Date that Met QC Criteria
Nov 13, 2007
First Posted Date
Nov 14, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 13, 2007
Last Update Posted Date
Nov 14, 2007Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socialsOTHER
Collaborators
Name
Class
Hoffmann-La Roche
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.
Detailed Description
Not provided
Conditions Module
Conditions
Rectal Neoplasms
Locally Advanced Rectal Adenocarcinoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
44Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
A
Experimental
-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
-Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
-Surgery (6-8 weeks after last bevacizumab dose)
-Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Drug: bevacizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
bevacizumab
Drug
-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14)
-Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days))
-Surgery (6-8 weeks after last bevacizumab dose)
-Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pathologic Complete Response Rate
after concomitant CT-RT treatment
Secondary Outcomes
Measure
Description
Time Frame
Complete Resection (R0) Rate
after surgery
Disease Free Survival
from complete response to relapse or disease-related death
Time to Failure Treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent from patients who are able to understand the study request
Histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; T3, operable T4 or TxN+
Karnofsky PS Index ≥ 70%
Life expectancy > 6 months
Adequate bone marrow, liver and renal function: ANC ≥ 1.5 x 10e9/l; Platelets ≥ 100 x 10e9/l; Hb ≥ 9g/dl; INR ≤ 1.5; Bilirubin ≤ 1.5 x ULN; ALT and/or AST ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis); Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis) or ≤ 10 x ULN (in case of bone metastasis); Creatinine clearance (Cockcroft-Gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x ULN
Exclusion Criteria:
Distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry
Surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study
Previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, INR ≤ 1.5); chronic use of high-dose aspirin (<325mg/day) or non-steroidal anti-inflammatory treatment
No integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs
Pregnant or lactating patients; SNC disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide SAEs or DPD deficiency
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Miquel Nogué, MD
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials