Status:
COMPLETED
A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00220051
Start Date
November 1 2001
Last Update
May 31 2013
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