CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision (NCT00174616)

01

Study 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

02

Conditions studied

Rectal Neoplasms

Browse trials for

Rectal Neoplasms 1,762

03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 87 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

05

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 87 participants (actual)

Study arms

Experimental
Single arm
Drug: Oxaliplatin, capecitabine, radiotherapy

Interventions

DrugOxaliplatin, 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

06

What researchers measure

Primary outcomes

MRI staging and TME surgery
Time frame: within 4 - 6 weeks after completion XELOX-RT

Secondary outcomes

Measure safety - NCI-CTC version 2
Time frame: from baseline to end of study

07

Study locations

7 sites

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

08

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID: NCT00174616
Lead sponsor: Sanofi
First posted: Sep 15, 2005
Start date: Jul 2003
Primary completion: Nov 2007
Completion: Nov 2007
Last update: Dec 7, 2009

Study contacts

Jean-Philippe Aussel

study director · Sanofi

View the source record on ClinicalTrials.gov ↗

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision