Surgical timing after radiotherapy for rectal cancer

STARRCAT: Surgical Timing After Radiotherapy for Rectal Cancer Analysis of Technique: a pilot randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88843062

Enrollment

Registered

2012-05-24

Start date

2012-06-06

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network, Generic Health Relevance and Cross Cutting Themes

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Operative Technical Complexity measured at time of surgical intervention	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026