Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01172860
Eligibility Criteria:
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:
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.
Additional exclusion criteria specifically regarding patients where Bleomycin is study drug:
11. Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.
12. Contraindication for bleomycin use: allergic reactions to bleomycin observed in previous treatment.
13. Contraindication for bleomycin use: if cumulative dose of 250mg BLM/m2 was previously exceeded.
Additional exclusion criteria specifically regarding patients where Cisplatin is study drug:
14. Patients with hypersensitivity to Cisplatin or other platinum compounds or to any of the excipients are to be excluded from receiving Cisplatin for the study.
15. Cisplatin is contraindicated in combination with live vaccines, including yellow fever vaccine.
16. Cisplatin is contraindicated in combination with phenytoin in prophylactic use.
17. Cisplatin is contraindicated in patients with myelosuppression.
18. Cisplatin is contraindicated in patients in a dehydrated condition (pre- and post-hydration is required to prevent serious renal dysfunction).
19. Cisplatin is contraindicated in patients with a pre-existing hearing impairment.
20. Cisplatin is contraindicated in patients with neuropathy caused by cisplatin.
21. Contraindication for Cisplatin use: Allergic reactions to Cisplatin observed in previous treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01172860
Study Brief:
Protocol Section:
NCT01172860