Condition category
Cancer
Date applied
24/05/2012
Date assigned
24/05/2012
Last edited
15/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.yeovilhospital.nhs.uk/

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27510524

Publication citations

Additional files

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.