CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

Rectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174616
• Other study ID #: C_8601
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 4, 2009
• Start date: July 2003
• Est. completion date: November 2007

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Primary objective:

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Frankfurt
Italy	Sanofi-Aventis Administrative Office	Milan
Netherlands	Sanofi-Aventis Administrative Office	Pe Gouda
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI staging and TME surgery		within 4 - 6 weeks after completion XELOX-RT	No
Secondary	Measure safety - NCI-CTC version 2		from baseline to end of study	Yes