None listed
Conditions
Brief summary
This study looks at the tolerability and effectiveness of an 11 week program of integrated radiotherapy and chemotherapy with oxaliplatin, 5-flurouracil (5-FU), folinic acid and the agent bevacizumab in patients with simultaneous primary and metastatic adenocarcinoma of the rectum (back passage)
Interventions
Single arm study - Integrated preoperative radiotherapy and chemotherapy over 11 weeks.
Treatment: drugs
Oxaliplatin (given intravenously): day 1 of each of weeks 1, 6 and 11 100mg/m2 given; day 1 of each of weeks weeks 3 and 8, 85 mg/m2 given.
Flurouracil: day 1 of each of weeks 1, 6 and 11 400mg/m2 bolus, given intravenously followed on day 1 by continuous infusion 2.4 g/m2, over 46 hours; on days of radiotherapy during both weeks 3-5 and weeks 8-10 - continuous infusion 200mg/m2/day ov
Single arm study - Integrated preoperative radiotherapy and chemotherapy over 11 weeks. Treatment: drugs Oxaliplatin (given intravenously): day 1 of each of weeks 1, 6 and 11 100mg/m2 given; day 1 of each of weeks weeks 3 and 8, 85 mg/m2 given. Flurouracil: day 1 of each of weeks 1, 6 and 11 400mg/m2 bolus, given intravenously followed on day 1 by continuous infusion 2.4 g/m2, over 46 hours; on days of radiotherapy during both weeks 3-5 and weeks 8-10 - continuous infusion 200mg/m2/day over 96 hours Leucovorin (given intravenously): day 1 of each of weeks 1, 6 and 11 200mg/m2 given. Bevacizumab (given intravenously): day 1 of each of weeks 1, 3, 5, 7, 9 and 11 - 5mg/kg Treatment: Other Radiation Therapy: in both weeks 3-5 and weeks 8-10 25.2Gy in 14 fractions over 2 weeks and 4 days. A total of 50.4 Gy in 1.8 Gy per fraction is given. The first 45 Gy is given to the pelvic volume and the final 5.4 Gy is given to a boost volume.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy. 2. Lower border of tumour must be within 15cm of anal verge. 3. Age >= 18 years. 4. Absolute neutrophil count >= 1.5 x 10^9/L, haemoglobin >= 90 g/L, platelet count >=100 x 10^9/L 5. ECOG performance status of <= 2 6. Adequate renal function: GFR >= 55 ml/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula). 7. Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal range, ALT/AST < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases, ALP < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases 8. No symptomatic peripheral neuropathy >= grade 2. 9. Males or non-pregnant, non-lactating females. Female patients of childbearing potential, not surgically sterilized, must take adequate contraceptive measures. 10. Has provided written informed consent for participation in this trial
Exclusion criteria
1. Prior pelvic radiotherapy 2. Febrile intercurrent illness or infection. 3. Previous history of unstable angina 4. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment 5. Acute coronary syndrome even if controlled with medication 6. Myocardial infarction within the last 12 months 7. Concurrent treatment with other anti-cancer therapy. 8. No medical co-morbidities that have the potential to be exacerbated by or contra-indicate therapy a. Uncontrolled hypertension b. Active bleeding disorders within the last 3 months c. Patients with NYHA Grade III/IV cardiac problems (e.g. congestive heart failure, or myocardial infarction or active myocardial ischemia within 12 months of study) d. Patients with active liver disease (e.g., chronic active hepatitis, cirrhosis). e. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection. f. Patients who have had major surgery within 28 days prior to commencing study drugs g. Patients with a serious non-healing wound, ulcer or bone fracture 9. Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities. 10. Locally recurrent rectal cancer 11. Female patients who are pregnant or breast-feeding 12. Medical or psychiatric conditions that compromises the patient's ability to give informed consent or to complete the protocol, or a history of non-compliance
Outcome results
None listed