Rectal Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
NCT number | NCT00220051 |
Other study ID # | 1973 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | September 19, 2005 |
Last updated | May 30, 2013 |
Start date | November 2001 |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological complete response rate. | |||
Primary | Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent. | |||
Secondary | Progression-free survival | |||
Secondary | Treatment related toxicity | |||
Secondary | Overall survival | |||
Secondary | Radiological response rate | |||
Secondary | Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan | |||
Secondary | Surgical complications | |||
Secondary | Bowel function and quality of life |
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