Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group
- Conditions
- ocally advanced rectal cancerMedDRA version: 20.0 Level: PT Classification code 10038046 Term: Rectal cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003057-42-DE
- Lead Sponsor
- niveristy Hospital Tuebingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 94
••Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
•Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal staging according to SOP MRI”
•Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
•Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
•Aged at least 18 years. No upper age limit.
•WHO/ECOG Performance Status = 1
•Adequate hematological, hepatic, renal and metabolic function parameters:
oLeukocytes = 3.000/mm^3
oANC = 2.000/mm^3
oPlatelets = 100.000/mm^3
oHb > 9 g/dl
oSerum creatinine = 1.5 x upper limit of normal
oCreatinin-Clearance = 30 ml / min
oBilirubin = 2.0 mg/dl, SGOT-SGPT, and AP = 3 x upper limit of normal
oInformed consent of the patient
•Informed consent of the 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 44
••Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
•cT4 tumors
•Positive lateral pelvic lymph nodes (s. SOP MRI)
•Distant metastases (to be excluded by CT scan of the thorax and abdomen)
•Preexisting fecal incontince for solid stool
•Preexisting peripheral sensory neuropathy with functional impairment
•Preexisting myelosuppression refleted by a neutrophil count < 2.000/mm^3 and/or platelets < 100.000/mm^3
•Severe impairment of kidney function with a Creatinin Clearance < 30 ml/min)
•Prior antineoplastic therapy for rectal cancer
•Prior radiotherapy of the pelvic region
•Major surgery within the last 4 weeks prior to inclusion
•Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•Subject (male or female) is not willing to use highly effective methods of contraception according to the Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 6 months (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasoing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
•On-treatment participation in an interventional clinical study in the period 30 days prior to inclusion
•Previous or current drug abuse
•Other concomitant antineoplastic therapy
•Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder, severe liver function disorders
•WHO/ECOG Performance Status > 1
•Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 6 months before enrolment.
•Chronic diarrhea (> grade 1 according NCI CTCAE)
•Prior or concurrent malignancy = 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free
•Known allergic reactions on study medication
•Known dihydropyrimidine dehydrogenase deficiency
•Medication inhibitors of the dihydropyrimidine dehydrogenase, such as Brivudin, Sorivudin and its analogues.
•Pernicious anemia or other anemias caused by Vitamin B-12 deficiency.
•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).
•Additionally for hyperthermia cardiac pacemakers and metal implants in the proximity of the pelvis constitute a criterion for exclusion.
1 Vasectomized partner is a h
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