ESPAC-5F: European Study group for Pancreatic Cancer - Trial 5F | Not Recruiting
ESPAC-5F: European Study group for ... | Not Recruiting
ESPAC-5F: European Study group for Pancreatic Cancer - Trial 5F
ESPAC-5F

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Topic: Cancer
  • Subtopic: Upper Gastro-Intestinal Cancer
  • Disease: Pancreas
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN89500674
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-chemotherapy-or-chemoradiotherapy-before-surgery-for-pancreatic-cancer-espac-5f
Research Details
  • 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.
Phase
Phase II
Study Design
Randomised; Interventional; Design type: Process of Care, Screening, Treatment
Study Type
Interventional
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
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 100; UK Sample Size: 85
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Liverpool
L69 3GL
Trial Contact(s)
Primary Trial Contact
Mrs Karen Scott
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
2013-003932-56
Funder(s)
  • Cancer Research UK (UK)
Other Study ID Numbers
16201
Sponsor(s)
University of Liverpool (UK)
Key Dates

Recruitment Start Date

26 Aug 2014

Recruitment End Date

26 Aug 2016

Trial Start Date

01 Apr 2014

Trial End Date

01 Aug 2017

Date added to source

03 Apr 2014

Date updated in source

22 Jul 2015