CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Oxaliplatin, capecitabine, radiotherapy

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

MRI staging and TME surgery

Secondary Outcome Measures

Measure safety - NCI-CTC version 2

Full Information

NCT ID

NCT00174616

First Posted

September 9, 2005

Last Updated

December 4, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00174616

Brief Title

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin, capecitabine, radiotherapy

Intervention Description

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 Outcome Measure Information:

Title

MRI staging and TME surgery

Time Frame

within 4 - 6 weeks after completion XELOX-RT

Secondary Outcome Measure Information:

Title

Measure safety - NCI-CTC version 2

Time Frame

from baseline to end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe Aussel

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name