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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

December 30, 2009
March 26, 2014
December 2009
March 2016   (final data collection date for primary outcome measure)
Rate complete pathologic responses [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043484 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Compare toxicities of these regimens [ 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 ]
Not Provided
Not Provided
 
Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • 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)
  • 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)
  • Experimental: A
    Bevacizumab + Capecitabine + Radiotherapy
    Intervention: Drug: Bevacizumab + Capecitabine + Radiotherapy
  • Active Comparator: B
    Capecitabine + Radiotherapy
    Intervention: Drug: Capecitabine + Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01043484
TTD-08-05, EudraCT: 2009-010192-24
No
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Hoffmann-La Roche
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
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP