Colorectal cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 16 year and over 2. Patients presenting with obstructing colorectal cancer, which is to be treated with palliative intent 3. Patients able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with impending or established perforation of the colon 2. Patients with low rectal cancer, i.e. a carcinoma in the lower third of the rectum 3. Patients being treated or considered for treatment with antiangiogenic drugs (e.g. bevacizumab) 4. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of Life is measured using the EORTC QLQ C30 at baseline and 3 months post-stenting (30 days for patients dying before 3 months) 2. Stent patency is measured using Stent Follow Up Form (completed by site) at 6 months post-stenting | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 01/10/2018: 1. Stenting success rate is measured by Stent Insertion Form (completed by site) at the time of stent insertion 2. Time to onset of stent related complications in the short term, intermediate term and long term is measured by Stent Follow Up Forms (completed by site) at 30 days post stenting, 1-3 months post stenting and 3-12 months post stenting 3. Stent related complication rates of patients on chemotherapy is measured by Stent Follow Up Form at 12 months 4. Cumulative frequency and duration of stoma formation is measured by Stent Follow Up Forms (as above), Intraoperative Form up to 12 months 5. Overall survival is measured by ONS data at 12 months. Stent Follow Up Forms record date of death (if applicable). However, we also obtain mortality data from ONS. 6. Cost effectiveness (cost per QALY) is measured by EQ-5D-5L; trial specific forms also collect some data which will be used to assess resource use 7. Quality of Life at 3 months measured using the QLQ-CR29 Disease Specific Module for Colorectal Cancer Secondary outcome measures as of 12/01/2018: 1. Stenting success rate is measured by Stent Insertion Form (completed by site) at the time of stent insertion 2. Time to onset of stent related complications in the short term, intermediate term and long term is measured by Stent Follow Up Forms (completed by site) at 30 days post stenting, 1-3 months post stenting and 3-12 months post stenting 3. Stent related complication rates of patients on chemotherapy is measured by Stent Follow Up Form at 12 months 4. Cumulative frequency and duration of stoma formation is measured by Stent Follow Up Forms (as above), Intraoperative Form up to 12 months 5. Overall survival is measured by ONS data at 12 months. Stent Follow Up Forms record date of death (if applicable). However, we also obtain mortality data from ONS. 6. Cost effectiveness (cost per QALY) is measured by EQ-5D-5L; trial specific forms also collect some data which | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales