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

NCT00557713 | Unknown Phase 2

• 1 other identifier: AVACROSS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms; Locally Advanced Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

  after concomitant CT-RT treatment

Secondary Outcomes (6)

• Complete Resection (R0) Rate

  after surgery

• Disease Free Survival

  from complete response to relapse or disease-related death

• Time to Failure Treatment

  from first treatment dose to drop out of the study

• Metastatic or Local Recurrence

  during study

• Toxicity Evaluation

  during study

Study Arms (1)

A

EXPERIMENTAL

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)

Drug: bevacizumab

Interventions

bevacizumab DRUG

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)

Also known as: Avastin

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

ACROSS

Barcelona, 08021, Spain

RECRUITING

Related Links

• across

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Miquel Nogué, MD

  Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: February 1, 2007
• Study Completion: October 1, 2013
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

ES (1)