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

September 17, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3-years disease- free-survival or 3-years overall survival

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events collection
Time Frame: From the signature of the informed consent up to the end of the study
From the signature of the informed consent up to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Iris CHAN, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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