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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00421824
First received: January 11, 2007
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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.

Condition Intervention Phase
Rectal Neoplasms
Drug: Oxaliplatin, capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate [ Time Frame: from the signature of Informed Consent up to the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative dose intensity [ Time Frame: from the signature of Informed Consent up to end of the study ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: from the signature of Informed Consent up to end of the study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: from the signature of Informed Consent up to end of the study ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: May 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Radiotherapy
Experimental: B 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 Name: Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421824

Locations
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: José Mª Taboada, Dr. Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00421824     History of Changes
Other Study ID Numbers: PM_L_0098, EudraCT # : 2005-005149-20
Study First Received: January 11, 2007
Last Updated: January 3, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Fluorouracil
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014