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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT01043484
First received: December 30, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Drug: Bevacizumab + Capecitabine + Radiotherapy
Drug: Capecitabine + Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • Rate complete pathologic responses [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival at 3 and 5 years [ Time Frame: 2009-2015 ] [ Designated as safety issue: No ]
  • Rate of local and distant recurrence at 3 and 5 years [ Time Frame: 2009-1015 ] [ Designated as safety issue: No ]
  • Overall survival at 3 and 5 years [ Time Frame: 2009-2015 ] [ Designated as safety issue: No ]
  • R0 resection rate. [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2009-2011 ] [ Designated as safety issue: Yes ]
  • Rate of surgery complications [ Time Frame: 2009-2011 ] [ Designated as safety issue: Yes ]
  • 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: 2009-2015 ] [ Designated as safety issue: No ]
  • Rate of sphincter preservation [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043484

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
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
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT01043484     History of Changes
Other Study ID Numbers: TTD-08-05, EudraCT: 2009-010192-24
Study First Received: December 30, 2009
Last Updated: March 26, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
Resectable rectal cancer
Radiotherapy
Bevacizumab
Capecitabine

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014