Rectal cancer And Pre-operative Induction therapy followed by Dedicated Operatio

• Conditions: Patients with a primary rectal cancer without detectable distantmetastasis who after locoregional therapy only, meaning preoperativeradio(chemo)therapy plus surgery have at least a 40% risk of nothaving a CRM negative resection or a recurrence, local or distant,within three years; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023957-12-SI
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-27
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 885

Inclusion Criteria

- Histological proof of newly diagnosed primary adenocarcinoma
of the rectum.
- Locally advanced tumour fulfilling at least one of the following
criteria on pelvic MRI indicating high risk of failing locally and/or
systemically (T4a, i.e. overgrowth to an adjacent organ or structure
like the prostate, urinary bladder, uterus, sacrum, pelvic floor or sidewall
(according to TNM version 5), cT4b, i.e. peritoneal
involvement, extramural vascular invasion (EMVI+). 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. Positive MRF (previously named CRM), i.e. tumor or
lymph node =< 1 mm from the mesorectal fascia [60]. Enlarged lateral
nodes, > 1 cm (lat LN+).
- Staging done within 4 weeks before randomization.
- No contraindications to chemotherapy, including adequate blood
counts:
white blood count >=4.0 x 109/L
platelet count >=100 x 109/L
clinically acceptable haemoglobin levels
creatinine levels indicating renal clearance of ?50 ml/min
bilirubin =<35 µmol/l.
- ECOG performance score =< 1
- Patient is considered to be mentally and physically fit for
chemotherapy as judged by the oncologist.
- Age >= 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- 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