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Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00263029
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE December 6, 2005
First Posted Date  ICMJE December 7, 2005
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE June 2002
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate). [ Time Frame: 3-years disease- free-survival or 3-years overall survival ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
Adverse events collection [ Time Frame: From the signature of the informed consent up to the end of the study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
Official Title  ICMJE Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
Brief Summary The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Neoplasms
Intervention  ICMJE
  • Drug: Oxaliplatin
    60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
  • Drug: Capecitabine
    500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart
  • Radiation: Radiotherapy
    Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2008)
18
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ECOG performance status score 0-1.
  • Chemo-naïve patients.
  • Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
  • Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
  • Adequate haematological, renal and liver functions as follows:

    • ANC > 3000ml
    • Platelet count > 100,000 ml
    • Urea & Serum Creatinine < 1.5 X upper limit of normal value
    • Total serum bilirubin < 1.5 X upper limit of normal value
    • ALT & AST < 3 X upper limit of normal value

Exclusion Criteria:

  • Prior chemotherapy.
  • Documented allergy to oxaliplatin or capecitabine.
  • Prior radiotherapy to pelvis.
  • Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
  • Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
  • Currently participating into another clinical trial with any investigational drug in the previous 30 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00263029
Other Study ID Numbers  ICMJE L_8479
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Iris CHAN, MD Sanofi
PRS Account Sanofi
Verification Date September 2008

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