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XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

This study is currently recruiting participants.
Verified November 2007 by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
ClinicalTrials.gov Identifier:
NCT00557713
First received: November 13, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 13, 2007
November 13, 2007
February 2007
Not Provided
Pathologic Complete Response Rate [ Time Frame: after concomitant CT-RT treatment ]
Same as current
No Changes Posted
  • Complete Resection (R0) Rate [ Time Frame: after surgery ]
  • Disease Free Survival [ Time Frame: from complete response to relapse or disease-related death ]
  • Time to Failure Treatment [ Time Frame: from first treatment dose to drop out of the study ]
  • Metastatic or Local Recurrence [ Time Frame: during study ]
  • Toxicity Evaluation [ Time Frame: during study ]
  • Surgical Morbility [ Time Frame: during surgery ]
Same as current
Not Provided
Not Provided
 
XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rectal Neoplasms
  • Locally Advanced Rectal Adenocarcinoma
Drug: bevacizumab
  1. -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)
  2. -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))
  3. -Surgery (6-8 weeks after last bevacizumab dose)
  4. -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Other Name: Avastin
Experimental: A
  1. -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)
  2. -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))
  3. -Surgery (6-8 weeks after last bevacizumab dose)
  4. -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Intervention: Drug: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
October 2013
Not Provided

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
Both
18 Years and older
No
Not Provided
Spain
 
NCT00557713
AVACROSS
No
Not Provided
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Hoffmann-La Roche
Study Chair: Miquel Nogué, MD Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP