Locally advanced rectal cancer MedDRA version: 20.0 Level: PT Classification code 10010033 Term: Colorectal cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10010034 Term: Colorectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10010023 Term: Colorectal neo
Conditions
Interventions
Trade Name: Beomycin
Bleomycin-baxter
Product Name: Bleomycin
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: BLEOMYCIN SULFATE
CAS Number: 9041-93-4
Concentration
Sponsors
Zealand University Hospital, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must be mentally capable of understanding the information given. 2. Patients must give written informed consent. 3. Histologically verified rectal tumor. 4. Men or women aged at least 18 years. 5. Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with neoadjuvant therapy followed by surgical excision (UICC stadium II-III). 6. ASA class I-III (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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Coagulation disorder. 2. Patients with ICD or pacemaker units. 3. Patients with epilepsy. 4. Pregnancy or lactation/breastfeeding. 5. Patients with known Hepatitis B/C or HIV infection. 6. Patients who have undergone treatment with bevacizumab within 4 weeks prior to enrolment in this trial. 7. Patients with concomitant use of phenytoin. 8. Patients with concomitant use of clozapine. 9. Concurrent treatment with an investigational medicinal product. 10. 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. 11. Patients with contraindications for PET/MRI scan: • Claustrophobia. • Implanted pacemaker. • Heart-valve prosthesis. • Cochlea / stapes prosthesis. • Insulin pumps that cannot be removed. • Neuro-stimulators. • Metal clips after operations. • Other metal devices and foreign bodies. • Metal shrapnel(s). • Inserted and fixed catheters i.e. Swan-Ganz catheters. • Shunts and prosthesis. 12. Advanced tumor stage, UICC stage IV. 13. Patients with Contraindications for bleomycin: • Acute pulmonary infection. • Medical history of severe pulmonary disease. • Previous allergic reactions to bleomycin. • Previous cumulative dose of bleomycin exceeding 250mg/m2. • Pre-existing renal dysfunction. Bleomycin treatment: Creatinine clearance must be greater than 40 ml/min. • Platelet count =50 mia/l. • Prothrombin time = 40 sec. 14. Patients registered in the Danish “Vævsanvendelsesregister”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to investigate the safety and efficacy of treating patients diagnosed with primary locally advanced rectal cancer with electrochemotherapy through an endoscopic system.;Secondary Objective: To investigate tumorreduction in PET/MRI, pathological tumor reduction (ypTNM), tumor regression (TRG), and intratumoral and systemic immunological response in patients diagnosed with primary locally advanced rectal cancer, treated with endoscopic assisted electrochemotherapy prior to intended curative surgery.;Primary end point(s): Safety: Any adverse or serious adverse events Efficacy: Reduction in tumor size prior to intended curative surgery. ;Timepoint(s) of evaluation of this end point: Safety: Continuous evaluation during the trial Pain and general health questionnaire incl. LARS at follow-up (6 weeks/12 weeks) Efficacy: Primary: Pathological evaluation of tumor (ypT/TRG) following surgery. Secondary: PET/MRI evaluation prior to surgery. Pathological tumor reduction (ypTNM) following surgery Tumor regression (TRG) following surgery Intratumoral and systemic immunological response prior/following surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumorreduction in PET/MRI. Intratumoral and systemic immunological response.;Timepoint(s) of evaluation of this end point: Tumorreduction in PET/MRI one week prior to surgery. Intratumoral and systemic immunological response prior/following surgery. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Surgery
Zealand University Hospital, Department of Surgery
Outcome results
None listed