ESPAC-5: European Study group for Pancreatic Cancer - Trial 5
| ISRCTN | ISRCTN89500674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89500674 |
| EudraCT/CTIS number | 2013-003932-56 |
| Secondary identifying numbers | 16201 |
- Submission date
- 03/04/2014
- Registration date
- 03/04/2014
- Last edited
- 16/12/2022
- 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
Contact information
Mrs Karen Scott
Scientific
Scientific
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 |
Study information
| 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 |
| Participant 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 |
| 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 |
| Study 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 |
| 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 physicians 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 investigators 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 |
Eligibility
| 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 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 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Research UK Liverpool Cancer Trials Unit
Liverpool
L69 3GL
United Kingdom
L69 3GL
United Kingdom
Sponsor information
University of Liverpool (UK)
University/education
University/education
Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
England
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
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 | 01/04/2021 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Basic results | 12/02/2022 | 20/05/2022 | No | No | |
| Results article | 12/12/2022 | 16/12/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/12/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
02/09/2022: Internal review.
20/05/2022: EU Clinical Trials Register results added.
20/01/2021: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2019 to 30/01/2021.
2. The intention to publish date has been changed from 31/12/2020 to 01/04/2021.
15/01/2019: The intention to publish date, 31/12/2020, was added.
27/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 26/08/2016 to 31/12/2018.
2. The overall trial end date was changed from 01/08/2017 to 31/12/2019.
22/07/2015: The overall trial end date was changed from 01/04/2015 to 01/08/2017.
