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
Contact information
Mr Arwel Lloyd
Scientific
Scientific
North Wales Cancer Treatment Centre
Ysbyty Glan Clwyd
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Study information
Study design | Multicentre non-randomised interventional treatment trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
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 | 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Irinotecan, capecitabine |
Primary outcome measure | 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) |
Secondary outcome measures | 1. Long-term survival outcomes (phase II only) 2. Assessment of late morbidity (phase II only) |
Overall study start date | 11/09/2003 |
Completion date | 20/12/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 142; UK sample size: 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
LL18 5UJ
United Kingdom
Sponsor information
Conwy and Denbighshire NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Glan Clwyd District Hospital
Rhyl
Denbighshire
LL18 5UJ
Wales
United Kingdom
Website | http://www.cd-tr.wales.nhs.uk/ |
---|---|
https://ror.org/03awsb125 |
Funders
Funder type
Industry
Pfizer
Government organisation / For-profit companies (industry)
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)
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 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 | 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 | |
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.