Rectal cancer And Pre-operative Induction therapy followed by DedicatedOperatio
- Conditions
- Primary rectal cancer with high risk of failing locally and/orsystemicallyMedDRA version: 14.1Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023957-12-ES
- Lead Sponsor
- niversity Medical Center Groningen (UMCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 885
Primary tumour characteristics
? Biopsy-proven, newly diagnosed primary rectal adenocarcinoma, i.e. with the lowest part of the tumour less than 16 cm from the anal verge using a rigid rectoscope or flexible endoscope.
? Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically:
o Clinical stage (c) T4a, i.e. overgrowth to an adjacent organ or structure like the
prostate, urinary bladder, uterus, sacrum, pelvic floor or side-wall (according to
TNM version 5).
o cT4b, i.e. peritoneal involvement.
o Extramural vascular invasion (EMVI+).
o N2, i.e. four or more lymph nodes in the mesorectum showing morphological
signs on MRI indicating metastatic disease. Four or more nodes, whether enlarged or not, with a rounded, homogeneous appearance is thus not sufficient.
o Positive MRF, i.e. tumor or lymph node one mm or less from the mesorectal
fascia.
o Metastatic lateral nodes, > 1 cm (lat LN+)., see appendix G
General
? Staging done within 5 weeks before randomization.
? No contraindications to chemotherapy, including adequate blood counts:
- white blood count > or = 4.0 x 109/L
- platelet count > or =100 x 109/L
- clinically acceptable haemoglobin levels
- creatinine levels indicating renal clearance of > or =50 ml/min
- bilirubin < 35 µmol/l.
? ECOG performance score < or = 1, see appendix B.
? Patient is considered to be mentally and physically fit for chemotherapy as judged by the oncologist.
? Age > or = 18 years
? Written informed consent.
? Adequate potential for follow-up.
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 885
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 885
? Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen.
? Presence of metastatic disease or recurrent rectal tumour. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn’s disease or active ulcerative Colitis.
? Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
? Known DPD deficiency.
? Any contraindications to MRI (e.g. patients with pacemakers).
? Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
? Concurrent uncontrolled medical conditions.
? Any investigational treatment for rectal cancer within the past month.
? Pregnancy or breast feeding.
? Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract.
? Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months.
? Patients with symptoms or history of peripheral neuropathy.
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