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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials.
Recruitment status was  Recruiting
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