EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for locally advanced rectal cancer
ISRCTN | ISRCTN86285819 |
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DOI | https://doi.org/10.1186/ISRCTN86285819 |
EudraCT/CTIS number | 2007-006701-25 |
ClinicalTrials.gov number | NCT00972881 |
Secondary identifying numbers | 4265 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 20/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Currently as of 08/03/2019:
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-cetuximab-capecitabine-and-irinotecan-with-radiotherapy-before-surgery-for-cancer-of-the-rectum
Previously:
https://www.cancerhelp.org.uk/trials/a-trial-looking-at-cetuximab-capecitabine-and-irinotecan-with-radiotherapy-before-surgery-for-cancer-of-the-rectum
Contact information
Scientific
Cancer Trials Office
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
Study information
Study design | Randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
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 | EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for locally advanced rectal cancer (North West/North Wales Clinical Oncology Group-04 on behalf of the NCRI rectal cancer subgroup): a phase II trial from the North West/North Wales Clinical Oncology Group on behalf of the NCRI rectal cancer subgroup examining the toxicity and efficacy of Cetuximab, Capecitabine and Irinotecan in combination with radiotherapy as preoperative downstaging treatment for MRI-defined locally advanced rectal cancer |
Study acronym | EXCITE |
Study objectives | To assess the downstaging effectiveness and tolerability of preoperative chemoradiation therapy (CRT) using capecitabine/irinortecan/cetuximab plus radiotherapy. Treatment summary: Patients will be treated with pelvic radiotherapy to a planned volume at a dose of 45 Gy in 25 daily fractions of 1.8 Gy treating 5 days per week from Monday to Friday for five weeks in total. Concurrently they will receive oral capecitabine at 650 mg/m^2 twice daily (bd) for 5 days per week on the days of radiotherapy only. In addition, they will receive intravenous (IV) irinotecan at 60 mg/m^2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy. In addition to this they will receive a loading dose of IV cetuximab at 400 mg/m^2 one week before the commencement of radiotherapy and then at 250 mg/m^2 once per week during the 1st, 2nd, 3rd 4th and 5th weeks of radiotherapy. On 20/10/2010 the following changes were made to this trial record: 1. The anticipated end date was changed from 30/03/2010 to 30/08/2011. 2. The phase was changed from phase I/II to phase II only. 3. The target number of participants was changed from 40 to 80. |
Ethics approval(s) | Oxford Research Ethics Committee REC B, 15/01/2008, ref: 08/H0605/6 |
Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Rectum |
Intervention | Patients will be treated with pelvic radiotherapy to a planned volume at a dose of 45 Gy in 25 daily fractions of 1.8 Gy treating 5 days per week from Monday to Friday for five weeks in total. Concurrently they will receive oral capecitabine at 650 mg/m^2 bd for 5 days per week on the days of radiotherapy only. In addition, they will receive IV irinotecan at 60 mg/m^2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy. In addition to this they will receive a loading dose of IV cetuximab at 400 mg/m^2 one week before the commencement of radiotherapy and then at 250 mg/m^2 once per week during the 1st, 2nd, 3rd 4th and 5th weeks of radiotherapy. Follow-up length: 36 months Study entry: registration only |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Capecitabine, irinortecan, cetuximab |
Primary outcome measure | Histologically confirmed R0 resection rate, measured at surgery when the tumour is resected (captured on Surgery CRF) |
Secondary outcome measures | 1. Radiotherapy compliance, measured during treatment weeks 2. Grade 3 or 4 toxicity, measured from treatment week 1 until end of follow-up month 36 3. Pathological complete response, measured at surgery when tumour is resected and examined 4. Morbidity, measured from surgery until end of follow-up month 36 5. Disease-free survival and local failure-free survival, measured from end of treatment until end of follow-up month 36 |
Overall study start date | 30/03/2009 |
Completion date | 30/08/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | Planned sample size: 80; UK sample size: 80 |
Total final enrolment | 82 |
Key inclusion criteria | Amended as of 20/10/2010: 1. Rectal cancer staged with magnetic resonance imaging (MRI) as locally advanced: 1.1. Mesorectal fascia threatened (tumour less than or equal to 1 mm from mesorectal fascia) 1.2. Mesorectal fascia involved or breached 1.3. Low tumours arising less than 5 cm from the anal verge 2. Histologically confirmed adenocarcinoma with lower (distal) limit less than or equal to 12 cm from the anal verge using rigid sigmoidoscopy 3. No evidence of metastatic disease 4. No pre-existing condition which would deter radiotherapy, e.g. fistulas, severe ulcerative colitis, Crohn's disease, prior adhesions 5. Estimated glomerular filtration rate (GFR) greater than 50 ml/min. If this is less than 50 ml/min a 24-hour urine collection for estimation of GFR is required or a serum EDTA clearance. 6. Absolute neutrophil count greater than or equal to 1.5 x 10^9/l 7. Platelets greater than or equal to 100 x 10^9/l, serum bilirubin less than 1.25 x upper limit of normal (ULN), serum transaminase less than 3 x ULN, serum ALP less than 5 x ULN 8. Fit to receive all study treatments 9. Able to comply with oral medication 10. Easter Cooperative Oncology Group (ECOG) performance status 0 or 1 11. Informed consent 12. Male and female, aged over 18 years Initial information at time of registration: 1. Magentic resonance imaging (MRI) defined locally advanced rectal cancer: 1.1. Mesorectal fascia involved, or 1.2. Mesorectal fascia threatened (tumour <1 mm from mesorectal fascia), or 1.3. Any T3 tumours less than 5 cm from anal verge 2. Histologically confirmed adenocarcinoma 3. No evidence of metastatic disease 4. No pre-existing condition which would deter radiotherapy, e.g. fistulas, severe ulcerative colitis, Crohn's disease, prior adhesions 5. Estimated glomerular filtration rate (GFR) greater than 50 ml/min. If this is less than 50 ml/min a 24-hour urine collection for estimation of GFR is required or a serum EDTA clearance. 6. Absolute neutrophil count greater than or equal to 1.5 x 10^9/l 7. Platelets greater than or equal to 100 x 10^9/l, serum bilirubin less than 1.25 x upper limit of normal (ULN), serum transaminase less than 3 x ULN, serum ALP less than 5 x ULN 8. Fit to receive all study treatments 9. Able to comply with oral medication 10. Easter Cooperative Oncology Group (ECOG) performance status 0 or 1 11. Informed consent 12. Male and female, aged over 18 years |
Key exclusion criteria | 1. Previous chemotherapy 2. Previous radiotherapy to the pelvis 3. Patients who have very significant small bowel delineated within the radiation fields 4. Current or impending rectal obstruction, metallic colonic stent in situ 5. Pelvic sepsis 6. Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent 7. Known dihydropyrimidine dehydrogenase deficiency 8. Pregnant, lactating or women of childbearing potential not using adequate contraception 9. World Health Organization (WHO) performance greater than 2 10. Gastrointestinal disorder which would interfere with oral therapy or oral bioavailability 11. Patients unsuitable for surgery because of co-morbidity or coagulation problems 12. Participation in other studies except genetic studies such as NSCCG |
Date of first enrolment | 30/03/2009 |
Date of final enrolment | 30/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W1T 4TJ
United Kingdom
Sponsor information
Government
Gower Street
London
WC1E 6BT
United Kingdom
Website | http://www.ucl.ac.uk |
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https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Basic results | No | No | |||
Protocol file | 07/05/2010 | No | No | ||
Abstract results | conference abstract | 20/01/2014 | No | No | |
Abstract results | conference abstract | 01/09/2015 | No | No | |
Abstract results | conference abstract | 01/11/2017 | No | No |
Additional files
Editorial Notes
20/05/2019: The total final enrolment was added.
08/03/2019: The following changes were made to the trial record:
1. Publication references added
2. Uploaded protocol version 4.0 07 May 2010 (not peer reviewed)
3. The plain English summary link was updated
4. Basic results (scientific) were added.
13/04/2017: No publications found in PubMed, verifying study status with principal investigator.