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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Oxaliplatin, Capecitabine
* Procedure: Pre operative radiotherapy
* Procedure: Surgical Resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin, Capecitabine|nan|
|Procedure: Pre operative radiotherapy|nan|
|Procedure: Surgical Resection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate. |  |  | 
| Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |