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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220051
First received: September 19, 2005
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Rectal Cancer
Drug: Oxaliplatin, Capecitabine
Procedure: Pre operative radiotherapy
Procedure: Surgical Resection
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: A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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

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

Enrollment: 109
Study Start Date: November 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00220051

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

No publications provided by Royal Marsden NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220051     History of Changes
Other Study ID Numbers: 1973
Study First Received: September 19, 2005
Last Updated: May 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014