Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm (radiochemotherapy)<br>single arm study (capecitabine, oxaliplatin) | Drug: Capecitabine<br>* chemotherapy oral use<br>* Other names: RO 09-1978;Drug: Oxaliplatin<br>* chemotherapy intravenous use<br>* Other names: (no trade name defined; investigators choice);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of T-downstaging (Reduction of the T-stadium) | surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) | at the time of final surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the toxicity grade III and IV of the therapy scheme | 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) | week 1 to max. week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative, Radiochemotherapy, Newly Diagnosed, Primary Operable, Locally Advanced, Rectal Carcinoma, T3, Lower Rectum, Middle Rectum, ABCSG, TAKO, 95, 05