Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Jake Foster
ORCID ID
Contact details
Yeovil District Hospital
Clinical Trials Office
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
-
Jake.foster@ydh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12185
Study information
Scientific title
STARRCAT: Surgical Timing After Radiotherapy for Rectal Cancer Analysis of Technique: a pilot randomised controlled trial
Acronym
STARRCAT
Study hypothesis
In patients with low rectal cancer receiving neo-adjuvant long-course chemoradiotherapy performing surgical resection at 12 weeks as opposed to 6 weeks after completion of the neoadjuvant therapy result in a less complex surgical procedure and improved outcomes?
Methodology:
A pilot randomised controlled trial. Surgery for low rectal cancer will be performed after a delay of either 6 or 12 weeks - the timing allocated by randomisation. Operations will be video-recorded, and the videos analysed using human reliability assessment techniques to evaluate the complexity of the procedure and the effect that this has upon the completeness of the surgical resection. Data will also be collected on peri-operative morbidity and mortality, quality of life, and patient experience.
Ethics approval
NHS South West REC Exeter, 16/05/2012, ref: 12/SW/0112
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network, Generic Health Relevance and Cross Cutting Themes; Subtopic: Colorectal Cancer, Rectum, Surgery
Intervention
12 weeks: surgery for rectal cancer performed following 12-week delay from completion of neo-adjuvant long-course chemoradiotherapy
6 weeks: surgery for rectal cancer performed following 6-week delay from completion of neo-adjuvant long-course chemoradiotherapy.
Follow Up Length: 1 month(s)
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Operative Technical Complexity measured at time of surgical intervention
Secondary outcome measures
1. Down-staging of disease as assessed on magnetic resonance imaging (MRI) measured at 6 weeks following completion of neo-adjuvant therapy +/- at 12 weeks
2. In-hospital surgical complications measured at time of discharge & also at 30-days post-operatively
3. Length of hospital inpatient admission measured by counting day of surgery as day 0 until day of discharge
4. Mortality measured 30 days from operation
5. Oncological clearance of tumour ("R0 resection") - Histopathological analysis of surgical resection specimen
6. Quality of life: EORTC QLQ-CR29 & C30 and EQ-5D-5L questionnaires measured pre-operatively
7. Post-operative on day of discharge from hospital measured 2-weeks after discharge in clinic
8. Quality of resected specimen assessed from high-definition photography of resected tumour specimens
9. Rates of sphincter preservation measured following surgery
10. Re-admission rates measured 30-days following operation
11. Surgeon-Reported Operative Complexity measured at using questionnaire completed by the operating surgeon at the end of each procedure
12. Tumour response to chemoradiotherapy measured using operative resection specimen assessed using standard histopathological techniques
Overall trial start date
06/06/2012
Overall trial end date
11/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 years or over
2. Completing neo-adjuvant long-course
3. Chemoradiotherapy for rectal cancer
4. Fit for surgical resection by open or laparoscopic anterior resection or abdominoperineal excision (APE)
5. American Society of Anaesthesiology (ASA) grades I, II and III
6. Able and willing to provide written consent
7. Target Gender: Male & Female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant exclusion criteria
1. Emergency admission or bowel obstruction/perforation
2. Short course radiotherapy regime
3. Anal cancer
4. Metastatic disease
5. Previous palliative pelvic radiotherapy
6. Rectal cancer on top of inflammatory bowel disease
7. Contra-indication to Magnetic Resonance Imaging scanning
8. Poor cognitive ability and/or unable to provide consent
9. Pregnancy
Recruitment start date
06/06/2012
Recruitment end date
31/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom
Sponsor information
Organisation
Yeovil District Hospital (UK)
Sponsor details
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27510524