Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study ID
NCT00909987
Phase
PHASE2
Status
Completed

Conditions

  • Rectum Cancer

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
  • Oxaliplatin — DRUG
    IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
  • Bevacizumab — DRUG
    IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
  • Radiotherapy — RADIATION
    Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
  • Capecitabine during all Radiotherapy period — DRUG
    825 mg/m2 bid
  • Total Mesorectal Excision (TME) — PROCEDURE
    4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Study Details

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.

Key Dates

First listed
May 29, 2009
Start date
Mar 31, 2009
Status verified
Sep 2013
Primary completion
Jan 31, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Neoadyuvant chemotherapy with XELOX: Xeloda 1000mg/m2/12h dayly, day one in the afternoon until day 15 in the morning; plus oxaliplatin 130mg/m2 (day 1); and Bevacizumab 7.5 mg/kg (day 1)during 3 cycles (each cycle of 3 weeks). Followed by a selective use of chemoradiotherapy with radiotherapy (50.4Gy, 28 sesions of 1.8Gy during 5 weeks) plus Xeloda 825mg/m2/12h dayly.

Primary Outcome Measure

Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria [ Time Frame: Until the end of study ]

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