A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

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. Identifier: NCT00220051
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Oxaliplatin, Capecitabine Procedure: Pre operative radiotherapy Procedure: Surgical Resection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
Study Start Date : November 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Pathological complete response rate.
  2. Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.

Secondary Outcome Measures :
  1. Progression-free survival
  2. Treatment related toxicity
  3. Overall survival
  4. Radiological response rate
  5. Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
  6. Surgical complications
  7. Bowel function and quality of life

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18.
  • Histological diagnosis of adenocarcinoma of rectum.
  • Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;

    • Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
    • Any T3 tumour at/below levatores
    • T3c tumour at any other level ie tumour extends >5 mm into peri-rectal fat
    • T4 tumour
    • Any T stage with 4 or more involved lymph nodes
  • WHO performance status 0, 1 or 2.
  • No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
  • Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
  • Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
  • Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
  • No concurrent uncontrolled medical conditions
  • No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
  • Adequate contraceptive precautions if relevant
  • Informed written consent

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Presence of metastatic disease or recurrent rectal tumour
  • Renal impairment (creatinine clearance<30 ml/min)
  • Pregnancy or breast feeding
  • Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
  • Participation in any investigational drug study within the previous 4 weeks.
  • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
  • Patients with any symptoms or history of peripheral neuropathy.
  • Prior pelvic radiotherapy

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 identifier (NCT number): NCT00220051

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: D Cunningham Royal Marsden NHS Foundation Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT00220051     History of Changes
Other Study ID Numbers: 1973
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

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