Radiotherapy, Irinotecan, Capecitabine then Excision for locally advanced rectal cancer

ISRCTN	ISRCTN59158409
DOI	https://doi.org/10.1186/ISRCTN59158409
Protocol serial number	1387
Sponsor	Conwy and Denbighshire NHS Trust (UK)
Funders	Pfizer, Roche

Submission date: 05/05/2010
Registration date: 05/05/2010
Last edited: 25/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-radiotherapy-and-chemotherapy-before-surgery-for-locally-advanced-rectal-cancer

Contact information

Mr Arwel Lloyd
Scientific

North Wales Cancer Treatment Centre
Ysbyty Glan Clwyd
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase I/II study of Radiotherapy, Irinotecan, Capecitabine then Excision for locally advanced rectal cancer
Study acronym	RICE (NWCOG - 2)
Study objectives	Phase I/II study. Phase I investigated the safety of preoperative neoadjuvant chemoradiation using radiotherapy combined with concurrent capecitabine and irinotecan for locally advanced rectal cancer before surgery, determining the recommended dose. Phase II of the study then used the recommended dose to assess the histological downstaging efficacy of this chemoradiation regimen, together with assessment of long-term survival end points and late radiation morbidity.
Ethics approval(s)	First MREC approved on the 18th March 2004 (ref: 04/4/015)
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Rectum
Intervention	Capecitabine: orally at 650 mg/m^2 twice daily (b.d.) throughout radiotherapy including weekends Irinotecan: 60 mg/m^2 intravenous (IV) once per week during the first 4 weeks of radiotherapy Radiotherapy: 45 Gy in 25 daily fractions over 5 weeks Follow-up length: 36 months
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Irinotecan, capecitabine
Primary outcome measure(s)	1. Determine safety and recommended dose of combination of radiotherapy, capecitabine and irinotecan (phase I only) 2. Histological pathological complete response rate (phase II only)
Key secondary outcome measure(s)	1. Long-term survival outcomes (phase II only) 2. Assessment of late morbidity (phase II only)
Completion date	20/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	142
Total final enrolment	47
Key inclusion criteria	1. Written informed consent given to participate in the trial 2. Male or female patients aged greater than or equal to 18 years old 3. World Health Organization (WHO) performance status 0, 1 or 2 4. Histologically confirmed previously-untreated carcinoma of the rectum with distal extent within 12 cm of the anal verge using a rigid sigmoidoscope 5. Deemed to be a candidate for preoperative downstaging chemoradiation due to: T3 disease on magnetic resonance imaging (MRI) scanning with disease less than or equal to 2 mm from the edge of the mesorectum or T4 disease on MRI scanning or any T3/T4 disease on MRI scanning with the distal extent of tumour less than or equal to 5 cm from the the anal margin 6. Adequate haematology: Neutrophil count greater than 1.5 x 10^9/l, platelet count greater than 100 x 10^9/l, Hb greater than 9 g/dl. The use of blood transfusions is allowed. 7. Adequate renal and hepatic function: serum creatinine = 1.5 x upper limit of normal (ULN), serum bilirubin = 1.25 x ULN, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase = 2.5 x ULN
Key exclusion criteria	1. Previous systemic chemotherapy 2. Previous radiotherapy to the planned exposure area 3. Those unfit for resection because of metastases 4. Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial protocol 5. Patients with a calculated creatinine clearance of less than 50 ml/min 6. Patients with loss of continuity of the upper gastrointestinal (GI) tract or malabsorbtion 7. Patients who have suffered a myocardial infarction within last year and/or have unstable angina, arrythmia or cardiac failure 8. Pregnancy or lactation. Patients of child bearing potential not implementing adequate contraception. 9. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin 10. Subjects considered by the investigator to be at risk of transmitting any infection through blood or other body fluid including Acquired Immune Deficiency Syndrome (AIDS), or other sexually transmitted disease or hepatitis 11. Patient participation in other studies 12. Partial or complete bowel obstruction (though patients in whom this has been relieved with a defunctioning stoma, are permitted to enter the trial)
Date of first enrolment	11/09/2003
Date of final enrolment	20/12/2006

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

North Wales Cancer Treatment Centre

Rhyl
LL18 5UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/09/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.