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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

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ClinicalTrials.gov Identifier: NCT00421824
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : January 4, 2011
Sponsor:
Information provided by:
Sanofi

January 11, 2007
January 12, 2007
January 4, 2011
May 2006
November 2010   (Final data collection date for primary outcome measure)
Response rate [ Time Frame: from the signature of Informed Consent up to the end of the study ]
Response rate
Complete list of historical versions of study NCT00421824 on ClinicalTrials.gov Archive Site
  • Relative dose intensity [ Time Frame: 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 ]
  • Overall survival [ Time Frame: from the signature of Informed Consent up to end of the study ]
  • Relative dose intensity
  • Disease free survival
  • Overall survival
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rectal Neoplasms
  • 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
  • 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
  • Experimental: A
    Intervention: Drug: Oxaliplatin, capecitabine
  • Experimental: B
    Intervention: Drug: Oxaliplatin, capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
Same as current
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00421824
PM_L_0098
EudraCT # : 2005-005149-20
Not Provided
Not Provided
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: José Mª Taboada, Dr. Sanofi
Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP