Patients with an advanced local rectal cancer (clinically staged as UICCstages II, III or IV) get a preoperative radiochemotherapy (RCT) combinedwith 5-fluorouracil (5-FU) and oxaliplatin followed by 3 cycles of FOLFOXchemotherapy (5-FU + folinic acid + oxaliplatin) and surgery [totalmesorectal excision (TME-surgery)]. Within the trial molecular and cellbiological (translational) analysis are done with biopsies and blood.
- Conditions
- Patients with advanced but resectable rectal cancer (clinically staged asrectal cancers of the UICC stages II, III or IV)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004228-37-DE
- Lead Sponsor
- niversitätsmedizin Goettingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
-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, cM+)
Staging requirements:
--Transrectal endoscopic ultrasound is the mandatory local staging
procedure,
--Additional high-resolution, thin-sliced (i.e. 3 mm) magnetic resonance
imaging (MRI) of the pelvis to classify infiltration depth and/or cN+
status or extramural venous cancer invasion (based on MRI-criteria)
--abdominal sonography and chest x-ray /or contrast-enhanced
computed tomography scan of the thorax and abdomen (and pelvis, if
EUS and/or MRI are not available) to complete UICC staging
classification
-Aged 18 to 80 years, inclusive
-WHO/ECOG status =2
-Life expectancy =weeks
-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 < threefold of upper level of normal range
-Creatinine clearance > 50ml/min, serum creatinine =1.5 mg/dl
-Written and signed informed consent of competent patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- Prior or concurrent malignancy (=3 years prior to enrolment in study)
except non-melanoma skin cancer or cervical carcinoma FIGO stage 0 1
if the patient is continuously disease-free patients with other tumors
that have been successfully treated and have not reappeared during the
last 3 years, may be included at the principal investigator's discretion
- Simultaneous therapy with other anti-cancer drugs
- Major surgery at the pelvic region 2-3 weeks prior to inclusion
- Previous multimodal treatment of rectal cancer
- Chronic colonic diseases
- Chronic diarrhea (>grade 1 according NCI CTCAE)
- Allergic reaction to platin-derivates or study medication
- Symptomatic neuropathia (NCI CTC =2)
- Simultaneous treatment with sorivudin and analogous
- Known Dihydropyrimidine dehydrogenase deficiency
- Cardiac infarction/failure within 3 months before start of multimodal
therapy
- Disseminated infection or sepsis
- Activated disseminated intravasal coagulopathia
- Subject pregnant or breast feeding, or planning to become pregnant
within 6 months after the end of treatment
- 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with
spermicidal jelly)
- Participation in an AMG-clinical trial in the period 30 days prior to
inclusion
- Current drug abuse
- Psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule (these conditions should be discussed with the patient before
registration in the trial)
- Insufficient compliance of the patient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method