Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer (AVAXEL)

October 18, 2016 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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
      • Madrid, Spain, 28046
        • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

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
  • Age ≥18 years
  • ECOG ≤ 1
  • Histologically confirmed carcinoma of the rectum
  • Localized and resectable rectal cancer
  • No metastatic disease
  • Measurable disease
  • Life expectancy more than 4 months
  • Non prior treatment for rectal cancer
  • Adequate haematological function: leu ≥ 4x 109 /l, Hb ≥10 gr/dl, neutropils≥ 1,5 x 109 /l and platelets ≥100 x 109 /l
  • Adequate renal function: creatinine ≤ 106 umol/l or calculated creatinine clearance > 50 mL/min
  • Adequate liver function: AST, ALT and alkaline phosphatase ≤2.5 x UL, bilirubin ≤1.5 x UL
  • Adequate nutritional weight loss <10% of regular weight and albumin ≥ 35 g/l

Exclusion Criteria:

  • Unresectable rectal cancer
  • Past or current history (within the last 5 years prior to treatment start) of other malignancies.
  • Patients of childbearing potential not willing to use effective means of contraception.
  • Clinically significant cardiovascular disease
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
  • Patients subjected to organ allografts who require immunosuppressive treatment.
  • Severe, non-cicatrized osseous fractures, wounds or ulcers.
  • Indications of hemorrhagic diathesis or coagulopathy.
  • Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
  • History of unexpected severe reactions to treatment with fluoropyrimidines or known deficiency dihydropyrimidine dehydrogenase deficiency (DPD).
  • Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study.
  • Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.5.
  • Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases).
  • Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study
  • Any psychological, familiar conditions suggesting that the patient will not be able to complete the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Bevacizumab + Capecitabine + Radiotherapy
Drug: Bevacizumab + Capecitabine + Radiotherapy
Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)
Active Comparator: B
Capecitabine + Radiotherapy
Drug: Capecitabine + Radiotherapy
Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate complete pathologic responses
Time Frame: 17 months
17 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival at 3 and 5 years
Time Frame: 78 months
78 months
Rate of local and distant recurrence at 3 and 5 years
Time Frame: 78 months
78 months
Overall survival at 3 and 5 years
Time Frame: 78 months
78 months
R0 resection rate.
Time Frame: 17 months
17 months
Adverse events
Time Frame: 17 months
17 months
Rate of surgery complications
Time Frame: 17 months
17 months
Molecular predictive markers: changes in angiogenic parameters, vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptors, microvessel quantification and angiopoietin-2 (Ang-2)
Time Frame: 17 months
17 months
Rate of sphincter preservation
Time Frame: 17 months
17 months

Collaborators and Investigators

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

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Collaborators

Hoffmann-La Roche

Investigators

  • Study Chair: Ramón Salazar, Institut Català d´Oncologia (ICO) L'Hospitalet. Barcelona. Spain
  • Study Chair: Cristina Grávalos, Hospital 12 Octubre. Madrid. Spain
  • Study Chair: Sebastiano Biondo, Hospital Universitario de Bellvitge.Barcelona. Spain
  • Study Chair: Amalia Palacios, Hospital Universitario Reina Sofía. Córdoba. Spain

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.

General Publications

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

December 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTD-08-05
  • EudraCT: 2009-010192-24

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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