Rectal Cancer
Conditions
Keywords
Preoperative, Radiochemotherapy, Newly Diagnosed, Primary Operable, Locally Advanced, Rectal Carcinoma, T3, Lower Rectum, Middle Rectum, ABCSG, TAKO, 95, 05
Brief summary
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
Detailed description
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited. The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
Interventions
DRUGCapecitabine
chemotherapy oral use
DRUGOxaliplatin
chemotherapy intravenous use
Sponsors
Sanofi-Synthelabo
Hoffmann-La Roche
Austrian Breast & Colorectal Cancer Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 - 80 * Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge) * According to MRI tumor extensions into the perirectal fat tissue (cT3) * No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma * WHO performance status 0 - 2 * Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml) * Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * Adequate renal function (creatinin - not more than 1.5 mg/dl) * Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study * Life expectancy of at least 3 month * Signed written Informed Consent before recruitment * Exclusion of distant metastases at the time of recruitment
Exclusion criteria
* Former radio- and/or chemotherapy * Tumor of the upper rectum * Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma) * Peripheral Neuropathy (NCI CTC - not higher than Grade 1) * General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine * Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders * Florid, serious infection at the time of recruitment * Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance * Evidence of lacking willingness for cooperation of the patient * Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of T-downstaging (Reduction of the T-stadium) | at the time of final surgery | surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the toxicity grade III and IV of the therapy scheme | week 1 to max. week 10 | from Visit 1 till surgery: weekly visits (visit 1 to visit 5) followed by final examination (performed 1 to 2 weeks after visit 5) before surgery followed by hospital admission (performed 1 to 2 weeks after final examination) followed by surgery ((performed 1 to 2 weeks after hospital admission) |
Countries
Austria
Outcome results
None listed