ISRCTN50181543
Completed
N/A
Phase II trial: Pre-operative, long-term chemoradiation with capecitabine, oxaliplatin and bevacizumab in locally advanced rectal cancer
niversity Medical Centre Schleswig-Holstein (Universitätsklinikum Schleswig-Holstein) (Germany)0 sites68 target enrollmentMay 9, 2008
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Centre Schleswig-Holstein (Universitätsklinikum Schleswig-Holstein) (Germany)
- Enrollment
- 68
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>18 years, both males and females
- •2\. Patients with histologically proven adenocarcinoma of the rectum, tumour \= 16 cm from the anal verge, u T3\-4 or uN\+ or Mason III/IV, staging will must be done by endorectal ultrasound and magnetic resonance imaging (MRI) or by endorectal unltrasound and high resolution computed tomography, no evidence of metastatic disease
- •3\. No prior treatment, except for ileostomy (if necessary due to ileus)
- •4\. No fistulas near the tumour
- •5\. Eastern Cooperative Oncology Group (ECOG) Performance Status \<\= 1
- •6\. Adequate bone marrow, hepatic and renal function:
- •6\.1\. Haemoglobin \>10\.0 g/dL, leucocyte count \> 3\.5 x 109/L, absolute neutrophil count \>1\.5 x 109/L, platelet count \>100 x 109/L
- •6\.2\. Alkaline phosphatase, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) \<3 x upper limit of normal (ULN)
- •6\.3\. Total bilirubin \<\= 2 mg/dL
- •6\.4\. Creatinine clearance \>50 mL/min
Exclusion Criteria
- •1\. No presence of adequate contraception in fertile patients
- •2\. Pregnant or breastfeeding women
- •3\. Previous or persistent alcohol or drug abuses
- •4\. Prior radiotherapy or chemotherapy to the pelvis, for any reason
- •5\. Treatment with any investigational drug, agent nor procedure, (i.e. did not participate in another trial) within 4 weeks before entry in this trial
- •6\. Treatment with other anti\-cancer agents
- •7\. Patients not able or willing to comply with the protocol treatment and investigations
- •8\. Patients with uncontrolled severe somatic or psychological diseases, e.g.:
- •8\.1\. Despite medication uncontrolled cardiac diseases, myocardial infarction within the last 6 months prior to enrolment
- •8\.2\. Neurological or psychiatric disorders including seizures and dementia
Outcomes
Primary Outcomes
Not specified
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