Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00263029
First received: December 6, 2005
Last updated: September 17, 2009
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00263029

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00263029     History of Changes
Other Study ID Numbers: L_8479
Study First Received: December 6, 2005
Last Updated: September 17, 2009
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on November 25, 2014