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

Phase 2
18 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate.

Principal Investigator

D Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms