Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jun 6, 2018

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• • Informed consent of the patient
• Exclusion Criteria:
• • 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
• • Distant metastases (to be excluded by CT scan of the thorax and abdomen)
• • Preexisting fecal incontinence for solid stool
• • Preexisting peripheral sensory neuropathy with functional impairment
• • Preexisting myelosuppression reflected 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"
• • 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.