CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00174616

Purpose

Primary objective:

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

Condition	Intervention	Phase
Rectal Neoplasms	Drug: Oxaliplatin, capecitabine, radiotherapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine Oxaliplatin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

MRI staging and TME surgery [ Time Frame: within 4 - 6 weeks after completion XELOX-RT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure safety - NCI-CTC version 2 [ Time Frame: from baseline to end of study ] [ Designated as safety issue: Yes ]

Enrollment:	87
Study Start Date:	July 2003
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single arm: Experimental	Drug: 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

Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174616

Locations

Belgium
Sanofi-Aventis
Diegem, Belgium
France
Sanofi-Aventis
Paris, France
Germany
Sanofi-Aventis
Berlin, Germany
Italy
Sanofi-Aventis
Milan, Italy
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Spain
Sanofi-Aventis
Barcelona, Spain
United Kingdom
Sanofi-Aventis
Guildford Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jean-Philippe Aussel

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	C_8601
Study First Received:	September 9, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00174616
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009