Back to resultsXELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Primary Purpose
Rectal Neoplasms, Locally Advanced Rectal Adenocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms
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
Sites / Locations
- ACROSSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
-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
Primary Outcome Measures
Pathologic Complete Response Rate
Secondary Outcome Measures
Complete Resection (R0) Rate
Disease Free Survival
Time to Failure Treatment
Metastatic or Local Recurrence
Toxicity Evaluation
Surgical Morbility
Full Information
NCT ID
NCT00557713
First Posted
November 13, 2007
Last Updated
November 13, 2007
Sponsor
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00557713
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Locally Advanced Rectal Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
-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)
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
-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)
Primary Outcome Measure Information:
Title
Pathologic Complete Response Rate
Time Frame
after concomitant CT-RT treatment
Secondary Outcome Measure Information:
Title
Complete Resection (R0) Rate
Time Frame
after surgery
Title
Disease Free Survival
Time Frame
from complete response to relapse or disease-related death
Title
Time to Failure Treatment
Time Frame
from first treatment dose to drop out of the study
Title
Metastatic or Local Recurrence
Time Frame
during study
Title
Toxicity Evaluation
Time Frame
during study
Title
Surgical Morbility
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miquel Nogué, MD
Organizational Affiliation
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Official's Role
Study Chair
Facility Information:
Facility Name
ACROSS
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Portal, MD
Email
inmaportal@teleline.es
First Name & Middle Initial & Last Name & Degree
Miquel Nogué, MD
First Name & Middle Initial & Last Name & Degree
Bernardo Queralt, MD
First Name & Middle Initial & Last Name & Degree
Carles Pericay, MD
First Name & Middle Initial & Last Name & Degree
Ferran Losa, MD
First Name & Middle Initial & Last Name & Degree
Isabel Moreno, MD
First Name & Middle Initial & Last Name & Degree
José María Roca, MD
First Name & Middle Initial & Last Name & Degree
Pilar Vicente, MD
First Name & Middle Initial & Last Name & Degree
Christian Rolfo, MD
First Name & Middle Initial & Last Name & Degree
Inmaculada Guasch, MD
First Name & Middle Initial & Last Name & Degree
Antonio Arriví, MD
First Name & Middle Initial & Last Name & Degree
Enrique Cabrera, MD
First Name & Middle Initial & Last Name & Degree
María José Safont, MD
First Name & Middle Initial & Last Name & Degree
Gaspar Esquerdo, MD
First Name & Middle Initial & Last Name & Degree
Ana Ruiz, MD
First Name & Middle Initial & Last Name & Degree
Antonieta Salud, MD
12. IPD Sharing Statement
Learn more about this trial
XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
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