Surgical timing after radiotherapy for rectal cancer

ISRCTN	ISRCTN88843062
DOI	https://doi.org/10.1186/ISRCTN88843062
Secondary identifying numbers	12185

Submission date: 24/05/2012
Registration date: 24/05/2012
Last edited: 15/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-surgery-following-treatment-rectal-cancer-starrcat

Contact information

Mr Jake Foster
Scientific

Yeovil District Hospital
Clinical Trials Office
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Email	Jake.foster@ydh.nhs.uk

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	STARRCAT: Surgical Timing After Radiotherapy for Rectal Cancer Analysis of Technique: a pilot randomised controlled trial
Study acronym	STARRCAT
Study objectives	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(s)	NHS South West REC Exeter, 16/05/2012, ref: 12/SW/0112
Health condition(s) or problem(s) studied	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
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 study start date	06/06/2012
Completion date	11/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
Key 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
Key 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
Date of first enrolment	06/06/2012
Date of final enrolment	31/05/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Yeovil District Hospital

Yeovil
BA21 4AT
United Kingdom

Sponsor information

Yeovil District Hospital (UK)
Hospital/treatment centre

Higher Kingston
Yeovil
BA21 4AT
England
United Kingdom

Website	http://www.yeovilhospital.nhs.uk/
"ROR"	https://ror.org/05dvbq272

Funders

Funder type

Government

NIHR Research for Patient Benefit Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2016		Yes	No

Editorial Notes

15/08/2016: publication reference added.
23/01/2014: the overall trial end date was changed from 08/12/2013 to 11/10/2014.