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

November 13, 2007 updated by: Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08021
        • Recruiting
        • ACROSS
        • Contact:
        • Principal Investigator:
          • Miquel Nogué, MD
        • Principal Investigator:
          • Bernardo Queralt, MD
        • Principal Investigator:
          • Carles Pericay, MD
        • Principal Investigator:
          • Ferran Losa, MD
        • Principal Investigator:
          • Isabel Moreno, MD
        • Principal Investigator:
          • José María Roca, MD
        • Principal Investigator:
          • Pilar Vicente, MD
        • Principal Investigator:
          • Christian Rolfo, MD
        • Principal Investigator:
          • Inmaculada Guasch, MD
        • Principal Investigator:
          • Antonio Arriví, MD
        • Principal Investigator:
          • Enrique Cabrera, MD
        • Principal Investigator:
          • María José Safont, MD
        • Principal Investigator:
          • Gaspar Esquerdo, MD
        • Principal Investigator:
          • Ana Ruiz, MD
        • Principal Investigator:
          • Antonieta Salud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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 Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response Rate
Time Frame: after concomitant CT-RT treatment
after concomitant CT-RT treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete Resection (R0) Rate
Time Frame: after surgery
after surgery
Disease Free Survival
Time Frame: from complete response to relapse or disease-related death
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
from first treatment dose to drop out of the study
Metastatic or Local Recurrence
Time Frame: during study
during study
Toxicity Evaluation
Time Frame: during study
during study
Surgical Morbility
Time Frame: during surgery
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Hoffmann-La Roche

Investigators

  • Study Chair: Miquel Nogué, MD, Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 13, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVACROSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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