Condition category
Cancer
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Emma Williams

ORCID ID

Contact details

Cancer Trials Office
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Additional identifiers

EudraCT number

2007-006701-25

ClinicalTrials.gov number

NCT00972881

Protocol/serial number

4265

Study information

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

Acronym

EXCITE

Study hypothesis

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

Oxford Research Ethics Committee REC B, 15/01/2008, ref: 08/H0605/6

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Capecitabine, irinortecan, cetuximab

Primary outcome measures

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 trial start date

30/03/2009

Overall trial end date

30/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 80; UK sample size: 80

Participant 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

Recruitment start date

30/03/2009

Recruitment end date

30/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Trials Office
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

Government

Website

http://www.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes