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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263029
First Posted: December 7, 2005
Last Update Posted: September 18, 2009
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.
Information provided by:
Sanofi
  Purpose
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.

Condition Intervention Phase
Rectal Neoplasms Drug: Oxaliplatin Drug: Capecitabine Radiation: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: From the signature of the informed consent up to the end of the study ]

Enrollment: 18
Study Start Date: June 2002
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263029


Sponsors and Collaborators
Sanofi
Investigators
Study Director: Iris CHAN, MD Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00263029     History of Changes
Other Study ID Numbers: L_8479
First Submitted: December 6, 2005
First Posted: December 7, 2005
Last Update Posted: September 18, 2009
Last Verified: September 2008

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents