Rectal Cancer
Conditions
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.
Interventions
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate. | — |
| Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Radiological response rate | — |
| Progression-free survival | — |
| Surgical complications | — |
| Bowel function and quality of life | — |
| Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan | — |
| Treatment related toxicity | — |
Outcome results
None listed