Treatment of bowel cancer using a different approach than surgery using a new device that makes the tumor absorb more drug while leaving the healthy tissue alone.

Phase 1

• Conditions: Colorectal cancer; MedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: HLTClassification code 10010039Term: Colorectal and anal neoplasms malignancy unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: HLTClassification code 10010040Term: Anal and colorectal neoplasms NECSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001248-23-DK
• Lead Sponsor: All Ireland Cooperative Oncology Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Histologically verified colorectal tumour.
2. Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate;
Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option;
Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
3. Men or women aged at least 18 years.
?4. Performance status (Karnofsky > 60% or ECOG/WHO < 2).
5. Treatment free interval of at least 2 weeks after previously applied therapy.
6. Patients must be mentally capable of understanding the information given.
7. Patients must give written informed consent.
8. a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- has had a hysterectomy
- has had a bilateral oophorectomy (ovariectomy) - has had a bilateral tubal ligation
- Is post-menopausal:
•Performance status (Karnofsky >60 OR WHO < 2).
•Treatment free interval of at least 2 weeks after previously applied therapy.
•Patients must be mentally capable of understanding the information given.
•Patients must give written informed consent.
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 10

Exclusion Criteria

1. Coagulation disorder
2. Patients with pre-existing renal dysfunction are excluded.
[Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.]
3. Patients with a clinically manifested arrhythmia or with a pacemaker
4. Patients with epilepsy.
5. Pregnancy or lactation/breastfeeding.
6. Patient known to be Hepatitis B/C or HIV positive.
7. Concurrent treatment with an investigational medicinal product or participation in another clinical study.
8. Patients who have undergone a regime of Bevacizumab in the previous 4 weeks.
9. 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 requirements.
10. Highly inflamed colon tissue which is ulcerated and bleeding.
11. patients with colorectal stent

Study & Design

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