Translational Validation Trial-B (add-on phase I/II study to the Clinical Research Unit (Klinische Forschergruppe) KFO179-2: Preoperative radiochemotherapy (RCT) combined with 5-fluorouracil (5-FU) and oxaliplatin followed by 3 cycles of FOLFOX chemotherapy (5-FU+folinic acid+oxaliplatin) and total mesorectal excision (TME-surgery) in advanced rectal cancer (clinically staged as UICC stages II, III or IV) accompanied by molecular and cell biological (translational) analysis.
- Conditions
- C20Malignant neoplasm of rectum
- Registration Number
- DRKS00004186
- Lead Sponsor
- niversitätsmedizin GöttingenGeorg-August-Universität
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Males and females with histologically confirmed resectable advanced primary rectal cancer of the lower thirds of the rectum (localized within 0 to 12 cm above the anocutaneous verge as measured by rigid rectoscopy), clinically (c) classified as cT3/cT4 or cN+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver metastases, pulmonary metastases)
- Aged 18 to 80 years, inclusive
- WHO/ECOG status =2
- Life expectancy >12weeks
- Adequate bone marrow function: WBC >3.0x109/L, neutrophils >1.5x109/L, thrombocytes >100x109/L, hemoglobin =10 g/dl
- Adequate liver function: bilirubin =2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range
- Creatinine clearance > 50ml/min, serum creatinine <1.5 mg/dl
- Written and signed informed consent of competent patient
1.Prior or concurrent malignancy except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is successfully treated. Patients with other tumors that have been successfully treated and have not reappeared during the last 3-5 years, may be included at the principal investigator’s discretion
2.Simultaneous therapy with other anti-cancer drugs
3.Major surgery at the pelvic region 2-3 weeks prior to inclusion
4.Previous chemotherapy (last 2 years before diagnosis of rectal cancer)
5.Chronic colonic diseases
6.Chronic diarrhea (>grade 1 according NCI CTCAE)
7.Allergic reaction to platin derivates or study medication
8.Known Dehydropyrimidindehydrogenase (DPD) deficiency
9.Symptomatic neuropathia (NCI CTC >1)
10. Concomitant treatment with sorivudin and analogous
11.Disseminated infection or sepsis
12.Disseminated intravascular coagulopathy
13.Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation
14.Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
15.Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol.
16.Participation in an AMG-clinical trial in the period 30 days prior to inclusion
17.Current drug abuse
18.neurological or psychiatric dysfunction including dementia or seizure disorder
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method