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Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Oxaliplatin, capecitabine
Oxaliplatin, capecitabine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with rectal adenocarcinoma.
  • Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
  • Rectal tumour at distal third, or
  • Tumours spread more than 5 mm in perirectal fat
  • Functional state ECOG ≤ 2.
  • Good hematological, hepatic and renal function

Exclusion Criteria:

  • Previous pelvis radiotherapy.
  • Previous antitumoural chemotherapy
  • Pregnant or breastfeeding women.
  • Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
  • History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
  • Clinically significant cardiovascular disease
  • Confirmed peripheral neuropathy.
  • Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
  • Blood disorders.
  • Intercurrent non-controlled or severe infections.
  • Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Relative dose intensity
Disease free survival
Overall survival

Full Information

First Posted
January 11, 2007
Last Updated
January 3, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00421824
Brief Title
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Official Title
Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary: To assess complete pathological response rate of both strategies. Secondary: Safety profile To assess downstaging rate of both strategies. To compare relative dose intensity of oxaliplatin and capecitabine of both strategies To compare time to progression and overall survival of both strategies.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, capecitabine
Other Intervention Name(s)
Radiotherapy
Intervention Description
OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, capecitabine
Other Intervention Name(s)
Radiotherapy
Intervention Description
XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
Primary Outcome Measure Information:
Title
Response rate
Time Frame
from the signature of Informed Consent up to the end of the study
Secondary Outcome Measure Information:
Title
Relative dose intensity
Time Frame
from the signature of Informed Consent up to end of the study
Title
Disease free survival
Time Frame
from the signature of Informed Consent up to end of the study
Title
Overall survival
Time Frame
from the signature of Informed Consent up to end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with rectal adenocarcinoma. Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or, Rectal tumour at distal third, or Tumours spread more than 5 mm in perirectal fat Functional state ECOG ≤ 2. Good hematological, hepatic and renal function Exclusion Criteria: Previous pelvis radiotherapy. Previous antitumoural chemotherapy Pregnant or breastfeeding women. Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months. History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer. Clinically significant cardiovascular disease Confirmed peripheral neuropathy. Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication. Blood disorders. Intercurrent non-controlled or severe infections. Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days. 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
José Mª Taboada, Dr.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

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