Locally advanced rectal cancer MedDRA 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)
Conditions
Sponsors
Univeristy Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion 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: o Leukocytes = 3.000/mm^3 o ANC = 2.000/mm^3 o Platelets = 100.000/mm^3 o Hb > 9 g/dl o Serum creatinine = 1.5 x upper limit of normal o Creatinin-Clearance = 30 ml / min o Bilirubin = 2.0 mg/dl, SGOT-SGPT, and AP = 3 x upper limit of normal o Informed 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
Exclusion criteria
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 (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 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 highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success 2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As primary endpoint, the rate of patients with a clinical complete response (cCR) will be determined. This rate will then be the basis for patient number calculations in a consecutive trial with 3-year loco-regional control as endpoint.;Secondary Objective: •Local regrowth rate •Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0) •Fecal incontinence according to Wexner-Vaizey Score •Quality of life according to EORTC QOL-C30 and QOL-CR29 •Frequency of Low anterior resection syndrome (LARS-scale) •Surgical morbidity and complications in patients undergoing surgery •Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery •R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery •Rate of sphincter-sparing surgery in patients undergoing surgery •Relapse-free survival (local / distant / overall) •Overall survival •Translational biomarker studies; cf. appendix for details ;Primary end point(s): As primary endpoint, the rate of patients with a clinical complete response (cCR) will be determined;Timepoint(s) of evaluation of this end point: end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Local regrowth rate • Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0) • Fecal incontinence according to Wexner-Vaizey Score • Quality of life according to EORTC QOL-C30 and QOL-CR29 • Frequency of Low anterior resection syndrome (LARS-scale) • Surgical morbidity and complications in patients undergoing surgery • Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery • R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery • Rate of sphincter-sparing surgery in patients undergoing surgery • Relapse-free survival (local / distant / overall) • Overall survival • Translational biomarker studies; cf. appendix for details ;Timepoint(s) of evaluation of this end point: after 4 years follow up | — |
Countries
Germany
Contacts
Public ContactSekretariat
Univeristy Hospital Tuebingen
Outcome results
None listed