Topic: National Cancer Research Network
Conditions
Interventions
Capecitabine: orally at 650 mg/m^2 twice daily (b.d.) throughout radiotherapy including weekends
Irinotecan: 60 mg/m^2 intravenous (IV) once per week during the first 4 weeks of radiot
Sponsors
Conwy and Denbighshire NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given to participate in the trial 2. Male or female patients aged greater than or equal to 18 years old 3. World Health Organization (WHO) performance status 0, 1 or 2 4. Histologically confirmed previously-untreated carcinoma of the rectum with distal extent within 12 cm of the anal verge using a rigid sigmoidoscope 5. Deemed to be a candidate for preoperative downstaging chemoradiation due to: T3 disease on magnetic resonance imaging (MRI) scanning with disease less than or equal to 2 mm from the edge of the mesorectum or T4 disease on MRI scanning or any T3/T4 disease on MRI scanning with the distal extent of tumour less than or equal to 5 cm from the the anal margin 6. Adequate haematology: Neutrophil count greater than 1.5 x 10^9/l, platelet count greater than 100 x 10^9/l, Hb greater than 9 g/dl. The use of blood transfusions is allowed. 7. Adequate renal and hepatic function: serum creatinine = 1.5 x upper limit of normal (ULN), serum bilirubin = 1.25 x ULN, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase = 2.5 x ULN
Exclusion criteria
Exclusion criteria: 1. Previous systemic chemotherapy 2. Previous radiotherapy to the planned exposure area 3. Those unfit for resection because of metastases 4. Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial protocol 5. Patients with a calculated creatinine clearance of less than 50 ml/min 6. Patients with loss of continuity of the upper gastrointestinal (GI) tract or malabsorbtion 7. Patients who have suffered a myocardial infarction within last year and/or have unstable angina, arrythmia or cardiac failure 8. Pregnancy or lactation. Patients of child bearing potential not implementing adequate contraception. 9. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin 10. Subjects considered by the investigator to be at risk of transmitting any infection through blood or other body fluid including Acquired Immune Deficiency Syndrome (AIDS), or other sexually transmitted disease or hepatitis 11. Patient participation in other studies 12. Partial or complete bowel obstruction (though patients in whom this has been relieved with a defunctioning stoma, are permitted to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determine safety and recommended dose of combination of radiotherapy, capecitabine and irinotecan (phase I only) 2. Histological pathological complete response rate (phase II only) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term survival outcomes (phase II only) 2. Assessment of late morbidity (phase II only) | — |
Countries
United Kingdom, Wales
Outcome results
None listed