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

ISRCTN ISRCTN59158409
DOI https://doi.org/10.1186/ISRCTN59158409
Secondary identifying numbers 1387
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

Study designMulticentre non-randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA phase I/II study of Radiotherapy, Irinotecan, Capecitabine then Excision for locally advanced rectal cancer
Study acronymRICE (NWCOG - 2)
Study objectivesPhase 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) studiedTopic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Rectum
InterventionCapecitabine: 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Irinotecan, capecitabine
Primary outcome measure1. Determine safety and recommended dose of combination of radiotherapy, capecitabine and irinotecan (phase I only)
2. Histological pathological complete response rate (phase II only)
Secondary outcome measures1. Long-term survival outcomes (phase II only)
2. Assessment of late morbidity (phase II only)
Overall study start date11/09/2003
Completion date20/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 142; UK sample size: 142
Total final enrolment47
Key inclusion criteria1. 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 criteria1. 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 enrolment11/09/2003
Date of final enrolment20/12/2006

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

North Wales Cancer Treatment Centre
Rhyl
LL18 5UJ
United Kingdom

Sponsor information

Conwy and Denbighshire NHS Trust (UK)
Hospital/treatment centre

Glan Clwyd District Hospital
Rhyl
Denbighshire
LL18 5UJ
Wales
United Kingdom

Website http://www.cd-tr.wales.nhs.uk/
ROR logo "ROR" https://ror.org/03awsb125

Funders

Funder type

Industry

Pfizer
Government organisation / For-profit companies (industry)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location
United States of America
Roche
Government organisation / For-profit companies (industry)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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
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.