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CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174616
Enrollment
87
Registered
2005-09-15
Start date
2003-07-31
Completion date
2007-11-30
Last updated
2009-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Brief 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

Interventions

* 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

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
MRI staging and TME surgerywithin 4 - 6 weeks after completion XELOX-RT

Secondary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026