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OpenTrials
Completed

NCT Number: NCT00174616

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

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

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Oxaliplatin, capecitabine, radiotherapy

Drug
  • 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

Primary outcomes

  1. MRI staging and TME surgery

    Time frame: within 4 - 6 weeks after completion XELOX-RT

Secondary outcomes

  1. Measure safety - NCI-CTC version 2

    Time frame: from baseline to end of study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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