Colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bleomycin
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentration unit: IU international unit(s)
Concentration type: equal
Concentrat
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must be mentally capable of understanding the information given. • Patients must give written informed consent. • Endoscopically suspected or histologically verified malignant tumor of the rectum or sigmoid colon. • Tumor described as passable at index endoscopy. • Men or women aged at least 18 years. • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. • ASA class I-II (Classification of the American Society of Anesthesiology) 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery • Uncorrectable coagulation disorder. • Patients with ICD or pacemaker units. • Ongoing immunosuppressive treatment. • Patients with concomitant use of phenytoin. • Myocardial insufficiency, defined as NYHA class >2 • Concurrent treatment with an investigational medicinal product. • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. • Advanced tumor stages, clinical UICC stage IV. • Acute surgical resection. • Pregnancy • Medical history of severe pulmonary disease. • Previous cumulative dose of bleomycin exceeding 250mg/m2. • BMI > 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this randomized trial, is to establish the safety and efficacy of electrochemotherapy in patients with colorectal cancer, as an additive treatment prior to intended curative surgery. The electroporation regime in this trial will be delivered through and endoscopic device, EndoVE®. The CliniporatorTM will be used for pulse generation;Secondary Objective: Secondary objective is to evaluate tumor response of the treatment. Furthermore, we plan to investigate local and systemic immunologic response;Primary end point(s): To investigate if electrochemotherapy is an efficient treatment modality for tumor down staging compared with electroporation alone prior to intended curative surgery in patients undergoing treatment for colorectal cancer.;Timepoint(s) of evaluation of this end point: Patients will be evaluated 5 times during a 30 day periode | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To investigate if electrochemotherapy will induce immunologic invasion of the primary tumor To investigate if the treatment will induce a systemic immunologic response. ;Timepoint(s) of evaluation of this end point: Patients will be evaluated 5 times during a 30 day periode | — |
Countries
Denmark
Contacts
Public ContactDepartment of Surgery
Zealand University Hospital
Outcome results
None listed