Status:
COMPLETED
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Lead Sponsor:
Sanofi
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary: * To assess complete pathological response rate of both strategies. Secondary: * Safety profile * To assess downstaging rate of both strategies. * To compare relative dose intensity of oxa...
Eligibility Criteria
Inclusion
- Patients with rectal adenocarcinoma.
- Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
- Rectal tumour at distal third, or
- Tumours spread more than 5 mm in perirectal fat
- Functional state ECOG ≤ 2.
- Good hematological, hepatic and renal function
Exclusion
- Previous pelvis radiotherapy.
- Previous antitumoural chemotherapy
- Pregnant or breastfeeding women.
- Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
- History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
- Clinically significant cardiovascular disease
- Confirmed peripheral neuropathy.
- Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
- Blood disorders.
- Intercurrent non-controlled or severe infections.
- Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00421824
Start Date
May 1 2006
End Date
November 1 2010
Last Update
January 4 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Barcelona, Spain