Experimental pre surgical treatment of rectal cancer using an endoscopic device in combination with systemic chemotherapy

Phase 1

• Conditions: ocally advanced rectal cancer; MedDRA version: 20.0Level: PTClassification code 10010033Term: Colorectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10010034Term: Colorectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000135-40-DK
• Lead Sponsor: Zealand University Hospital, Department of Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-05
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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”

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified