Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy
NCT ID: NCT01434147
Last Updated: 2014-03-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-10-31
Study Completion Date
2013-08-31
Brief Summary
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Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
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Detailed Description
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Induction chemotherapy combined with Radio chemotherapy:
Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during 14 days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1; repetition day 22 and 43 (3 cycles)
Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy:
Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m² bid, on each radiation day during the first 4 weeks of RCTx
Surgery according to TME-criteria (total mesorectal excision) in compliance of an interruption of min. 14 days after RCTx
Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during 14 days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1; repetition day 22 and 43 (3 cycles)
Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy:
Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m² bid, on each radiation day during the first 4 weeks of RCTx
Surgery according to TME-criteria (total mesorectal excision) in compliance of an interruption of min. 14 days after RCTx
Conditions
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Rectal Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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induction chemotherapy + radiochemotherapy
preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine induction chemotherapy: starts within 28 days after bioptical diagnosis. All patients are administered with capecitabine (Xeloda®) 1000 mg/m2 bid during 14 days (d1-d14), oxaliplatin 130 mg/m2 and bevacizumab (Avastin®) 7.5 mg/kg body weight on day 1; repetition days 22 and 43 (3 cycles) Combined radiochemotherapy: starts at the earliest one week after concluded third cycle of induction chemotherapy. Radiotherapy takes place on 5 x 5 days (dose: 1.8 Gy; cumulative dose: 45 Gy). For chemotherapy patients are administered with capecitabine (Xeloda®) 825mg/m² bid, on each radiation day during the first 4 weeks of radiochemotherapy.
Group Type
EXPERIMENTAL
preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine
Intervention Type
DRUG
Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Interventions
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preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine
Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Intervention Type
DRUG
Other Intervention Names
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Xeloda (capecitabine)
Avastin (bevacizumab)
Oxaliplatin
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Sponsor Role
collaborator
Austrian Breast & Colorectal Cancer Study Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dietmar Öfner, MD, Head
Role: STUDY_CHAIR
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD, Head
Role: STUDY_CHAIR
Austrian Breast & Colorectal Cancer Study Group
Wolfgang Eisterer, MD
Role: STUDY_CHAIR
Austrian Breast & Colorectal Cancer Study Group
Locations
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Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria
Site Status
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, Austria
Site Status
Medical University Graz, Oncology
Graz, Styria, Austria
Site Status
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, Austria
Site Status
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Site Status
Medical University of Vienna, General Hospital
Vienna, Vienna, Austria
Site Status
State Hospital Feldkirch, Radiotherapy
Feldkirch, Vorarlberg, Austria
Site Status
Countries
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Austria
References
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Related Links
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http://abcsg.at
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-024354-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABCSG R05
Identifier Type: -
Identifier Source: org_study_id
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