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

Royal Marsden NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Rectal Cancer

Treatments

Procedure: Surgical Resection

Drug: Oxaliplatin, Capecitabine

Procedure: Pre operative radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00220051

1973

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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