ESPAC-5: European Study group for Pancreatic Cancer - Trial 5

Plain English Summary

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-chemotherapy-or-chemoradiotherapy-before-surgery-for-pancreatic-cancer-espac-5f

Study website

Type

Scientific

Contact name

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

EudraCT/CTIS number

2013-003932-56

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

16201

Scientific title

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

Acronym

ESPAC-5

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.

Ethics approval(s)

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

Study setting(s)

Hospital

Study 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

Mixed

Primary outcome measure

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 study start date

01/04/2014

Overall study end date

30/01/2021

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 85

Total final enrolment

90

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

31/12/2018

Countries of recruitment

England, United Kingdom

Study participating centre

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

Organisation

University of Liverpool (UK)

Sponsor details

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

Sponsor type

University/education

Website

ROR

https://ror.org/04xs57h96

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 organizations

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/04/2021

Individual participant data (IPD) Intention to share

No

IPD sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs