Rectal Cancer Clinical Trial
Official title:
Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)
Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Status | Completed |
Enrollment | 25 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 18-80 years - Histologic confirmation of rectal adenocarcinoma stage cT3 (= 5mm to the mesorectal fascia)/cT4( primary curative intention)NxM0 - No former chemotherapy, no former radiotherapy of the pelvic, no former tumour resection of a rectal carcinoma - General condition WHO grade 0-2 - Adequate bone marrow reserve ( leucocytes =3 000/µl, thrombocytes =100 000/µl) - Adequate renal function (creatinine = 1,5 mg/dl, creatinine clearance > 50ml/min (Cockcroft and Gault formula)) - Adequate liver function (bilirubin =1,5x ULN, GOT and GPT =3,5xULN) - Exclusion of pregnancy for women with childbearing potential (negative pregnancy test urine or serum) - Female patients with childbearing potential and male patients that are not surgically sterile must be practicing a medically acceptable contraceptive regimen while on study treatment until 3 months after the end of the study (e.g. oral contraceptives, condom, intrauterine device) - Life expectancy of at least 3 months - INR and aPTT = 1,5 x LLN - Provision of signed informed consents before registration Exclusion Criteria: - Rectal carcinoma stage cT3 (> 5mm from the mesorectal fascia) all stages <cT3, M1 - Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin - General contraindication or known hypersensitivity against Bevacizumab, Capecitabine and Oxaliplatin - Not malignant diseases for which treatment with radiotherapy, resection of the rectum and treatment with chemotherapy (Bevacizumab, Capecitabine) is contraindicated: uncontrolled hypertension (systolic > 150 mmHG and/or diastolic > 100 mmHG) or clinically significant (e.g. active) cardiovascular diseases: CVA (cardiovascular accident)/ apoplectic insult (= 6 months prior to registration), myocardial infarction (= 6 months prior to registration), unstable angina pectoris, CHF(congestive heart failure) with NYHA (New York heart Association) Grade II or higher, cardiac arrhythmia requiring therapy, hepatic diseases, significant neurologic or psychiatric disorders - Florid, serious infection at registration - Peripheral neuropathy (NCI CTCAE v 4.0 = grade 1) - Juridically limited contractual capability, indication of neurological or psychiatric disease which constrains upon investigators opinion the patients capability to adhere to the study routines - Major surgical procedure within 28 days prior start of the study, open wounds - Significant traumatic injury, bone fracture, unhealed wounds - Patients with spinal cord compression or metastases in the central nervous system - Indication of bleeding diathesis or coagulopathy - Intake of anticoagulant or thrombolytic agents and/or Aspirin > 325 mg/d within 10 days prior to registration - Current or recent (within 10 days prior to treatment start) therapy with full dosed anticoagulants. Preventive therapy is allowed. - Previous thromboembolic or haemorrhagic events within 6 months prior to registration - Previous abdominal fistulas, gastro-intestinal perforation or intrabdominal abscesses within 6 months prior to registration - Treatment with another investigational drug within 28 days prior to registration - Patients with malabsorption syndrome or difficulties in swallowing - Indication of poor compliance of the patient - Pregnant or breast-feeding women - Proteinuria: Dipstick <2+. If the Dipstick is =2+ protein has to be estimated in the 24 hours urine. The value should not be higher then 1g/24 hours. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | State Hospital Feldkirch, Radiotherapy | Feldkirch | Vorarlberg |
Austria | Medical University Graz, Oncology | Graz | Styria |
Austria | Medical University Innsbruck, Internal Medicine | Innsbruck | Tyrol |
Austria | Paracelsus Medical University Salzburg - Oncology | Salzburg | |
Austria | Hospital BHB St. Veit/Glan, Surgery | St. Veit a. d. Glan | Carinthia |
Austria | Medical University of Vienna, General Hospital | Vienna | |
Austria | Klinikum Wels-Grieskirchen | Wels | Upper Austria |
Lead Sponsor | Collaborator |
---|---|
Austrian Breast & Colorectal Cancer Study Group | Hoffmann-La Roche |
Austria,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | termination of therapy | before surgery (after conclusion of therapy phase) | up to 17 weeks | Yes |
Primary | occurence of toxicity | until timepoint of discharge of patient | up to 18-19 weeks | Yes |
Secondary | collection of response rate | T- and N-downstaging, pathological complete remission: measurement at the timepoint of surgery | up to week 18 | No |
Secondary | post-surgery morbidity | according to Accordion; measurement at the timepoint of discharge of patient | after 18-19 weeks | Yes |
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