CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
NCT ID: NCT00174616
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2003-07-31
2007-11-30
Brief Summary
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* Pathological complete response (ypT0N0) rate
Secondary objectives:
* Histopathological R0 resection rate
* Pathological downstaging (ypT0-T2N0) rate
* One month surgical complication rate
* Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
* Safety
* Local and distant recurrence rates
* Progression-free survival
* Overall survival
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
Oxaliplatin, capecitabine, radiotherapy
* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses
* Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks
* Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks
Interventions
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Oxaliplatin, capecitabine, radiotherapy
* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses
* Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks
* Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks
Eligibility Criteria
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Inclusion Criteria
* No evidence of distant spread
* No prior therapy for chemotherapy or radiation therapy for rectal cancer
* Patient considered locally advanced by MRI:
* Tumour beyond mesorectal fascia, or
* Tumour ≤ 2mm from mesorectal fascia, or
* T3 tumour \< 5cm from anal verge
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No peripheral neuropathy \> grade1
* ECOG PS ≤ 2
* ANC \> 1,500 x 10\^9/L
* Platelets \> 100,000 x 10\^9/L
* Creatinine \< 1.5 x IULN
* Bilirubin \< 1.5 IULN
* SGPT (ALT) \< 2.5 IULN
* No pre-existing condition which would deter chemoradiotherapy
* No uncontrolled diarrhoea or fecal incontinence
* No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields
* No other serious uncontrolled concomitant illness
* Informed consent signed
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Jean-Philippe Aussel
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Frankfurt, , Germany
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Pe Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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Other Identifiers
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C_8601
Identifier Type: -
Identifier Source: org_study_id