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

January 3, 2011 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Oxaliplatin, capecitabine
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
Other Names:
  • Radiotherapy
Drug: Oxaliplatin, capecitabine
XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
Other Names:
  • Radiotherapy
Experimental: B
Drug: Oxaliplatin, capecitabine
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
Other Names:
  • Radiotherapy
Drug: Oxaliplatin, capecitabine
XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
Other Names:
  • Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: from the signature of Informed Consent up to the end of the study
from the signature of Informed Consent up to the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative dose intensity
Time Frame: from the signature of Informed Consent up to end of the study
from the signature of Informed Consent up to end of the study
Disease free survival
Time Frame: from the signature of Informed Consent up to end of the study
from the signature of Informed Consent up to end of the study
Overall survival
Time Frame: from the signature of Informed Consent up to end of the study
from the signature of Informed Consent up to end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 12, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM_L_0098
  • EudraCT # : 2005-005149-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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