A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age over 18.
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Histological diagnosis of adenocarcinoma of rectum.
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Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;
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Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
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Any T3 tumour at/below levatores
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T3c tumour at any other level ie tumour extends >5 mm into peri-rectal fat
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T4 tumour
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Any T stage with 4 or more involved lymph nodes
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WHO performance status 0, 1 or 2.
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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.
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Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
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Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
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Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
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No concurrent uncontrolled medical conditions
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No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
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Adequate contraceptive precautions if relevant
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Informed written consent
Exclusion Criteria:
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Medical or psychiatric conditions that compromise the patient's ability to give informed consent
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Presence of metastatic disease or recurrent rectal tumour
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Renal impairment (creatinine clearance<30 ml/min)
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Pregnancy or breast feeding
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Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
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Participation in any investigational drug study within the previous 4 weeks.
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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)
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Patients with any symptoms or history of peripheral neuropathy.
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Prior pelvic radiotherapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
Investigators
- Principal Investigator: D Cunningham, Royal Marsden NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1973