Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT00828672
Phase
PHASE2
Status
Completed

Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Administered on days 15,22,29,36 en 43; 50 mg/m2
  • Bevacizumab — DRUG
    Administered on days 1,15,29 and 43 ; 5mg/kg
  • Capecitabine — DRUG
    825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
  • radiotherapy — RADIATION
    Total dose 45Gy

Study Details

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated. To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Key Dates

First listed
Jan 26, 2009
Start date
Jun 30, 2009
Status verified
Jul 2019
Primary completion
Mar 31, 2014
Completion
Mar 31, 2019

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AXE (ARM 1)
    Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
  • Active Comparator: AX (ARM 2)
    Bevacizumab and Capecitabine concurrently with radiotherapy

Primary Outcome Measure

Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. [ Time Frame: 4 months ]

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