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

Phase 2

Completed

• Conditions: Rectal Neoplasms
• Interventions: Drug: Oxaliplatin, capecitabine

• Registration Number: NCT00421824
• Lead Sponsor: Sanofi

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 oxaliplatin and capecitabine of both strategies

* To compare time to progression and overall survival of both strategies.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-03
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oxaliplatin, capecitabine	-
B	Oxaliplatin, capecitabine	-

Primary Outcome Measures

Name	Time	Method
Response rate	from the signature of Informed Consent up to the end of the study

Secondary Outcome Measures

Name	Time	Method
Disease free survival	from the signature of Informed Consent up to end of the study
Overall survival	from the signature of Informed Consent up to end of the study
Relative dose intensity	from the signature of Informed Consent up to end of the study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain