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

Phase 2

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT00220051
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate.
Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.

Secondary Outcome Measures

Name	Time	Method
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