Condition category
Cancer
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
22/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Karen Scott

ORCID ID

Contact details

Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C
Waterhouse Building 3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
-
K.Billington@liv.ac.uk

Additional identifiers

EudraCT number

2013-003932-56

ClinicalTrials.gov number

Protocol/serial number

16201

Study information

Scientific title

ESPAC - 5F: European Study Group for Pancreatic Cancer - Trial 5F: four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy

Acronym

ESPAC-5F

Study hypothesis

ESPAC-5: a multi-centre, prospective, randomised, feasibility Phase II trial comparing neoadjuvant therapy to immediate surgical exploration in patients with borderline resectable pancreatic cancer. The aim of this study will be to compare neoadjuvant chemotherapy (GemCap or FOLFIRINOX) or chemoradiotherapy with immediate surgery. All patients who undergo resection will also receive adjuvant chemotherapy as standard.

On 22/07/2015 the overall trial end date was changed from 01/04/2015 to 01/08/2017.

Ethics approval

NRES Committee North West - Haydock; 18/03/2014; ref.: 14/NW/0036

Study design

Randomised; Interventional; Design type: Process of Care, Screening, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet will be available online shortly. In the meantime please contact Karen Scott on 0151 795 5269 or email k.billington@liv.ac.uk to request a copy

Condition

Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas

Intervention

If eligible for the study patients will be randomised onto one of the following arms.

Arm A (control): Surgery. Eligible patients will undergo surgical exploration for resection within two weeks of randomisation. Following recovery from successful resection (up to 12 weeks) patients will undergo standard adjuvant chemotherapy either gemcitabine or 5-fluorouracil for six cycles ie. 24 weeks. If patients do not undergo successful resection then following recovery from surgery, further therapy will be as physician’s choice. Patients will be followed up for 12 months after randomisation.

Arm B: GEMCAP. Within two weeks of randomisation, eligible patients will commence neoadjuvant Gemcitabine, 1000mg/m2 iv infusion over 30 mins, once a week for 3 of 4 weeks and capecitabine 830mg/m2 BD PO for 21 /28d, (one cycle) for 2 cycles i.e. 8 weeks . Four to six weeks after completion chemotherapy patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A.

Arm C: FOLFIRINOX - Within two weeks of randomisation, eligible patients will commence neoadjuvant Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, Folinic acid 400mg/m2, 5-FU 2400mg/m2 46 hour infusion, repeated every 2 weeks for 4 cycles. Growth factor support may be administered at the investigator’s discretion. Four to six weeks after completion chemotherapy patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A.

Arm D: CRT. Within two weeks of randomisation, eligible patients will commence neoadjuvant CRT delivering a total dose of 50.4Gy in 28 daily fractions over 5 1/2 weeks (1.8Gy/#fraction Mon to Fri) with Capecitabine 830mg/m2 BD PO (Mon to Fri) throughout radiotherapy. Centres would be required to choose to use IMRT (preferred) or 3D conformal RT for all their patients. Four to six weeks after completion CRT patients will undergo staging CT scan. If there has been no progression patients will then undergo surgical exploration within two weeks as for Arm A.

Patients will be followed up for 12 months after randomisation.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

1. Recruitment rate
Recruitment rate will be measured by the proportion of centres that successfully engage in the study and by the overall recruitment. Centres will be classified as successfully engaged if the study has opened in a timely fashion and if they are achieving over 50% of the recruitment and randomisation rate estimated for their centre. The overall recruitment rate will be deemed successful if at least 80% of the centres have fully engaged in the study and the target rate has been achieved (100 patients in 24 months).

2. Resection rate
An overall resection rate will be measured using the total number of patients at baseline. A second resection rate will also be measured using only the patients who undergo explorative surgery. R1 and R0 resection margins will be used when measuring the resection rate – R2 resection margins will be excluded.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2014

Overall trial end date

01/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Borderline resectable mass in the pancreatic head as defined by CT criteria.
2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants).
3. Able to undergo biliary drainage using a fully covered self expanding metal stent.
4. Age = 18 years.
5. WHO performance status 0, 1.
6. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l.
7. Serum bilirubin =1.5 ULN.
8. Calculated creatinine clearance > 50ml/min
9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.
10. Written informed consent; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 85

Participant exclusion criteria

1. Distant metastatic disease
2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)
3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection.
4. Previous chemotherapy or chemoradiotherapy
5. Pregnancy
6. WHO performance status 24
7. New York Heart Association Classification Grade III or IV
8. Patients with known malabsorption

Recruitment start date

26/08/2014

Recruitment end date

26/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Liverpool Cancer Trials Unit
Liverpool
L69 3GL
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (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