Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ESPAC-1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 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
Cancer of pancreas
Intervention
All patients undergo surgical resection followed by randomisation to one of four treatment arms:
1. Arm A: Radiotherapy, a split course of 40 Gy with a 2 week separation between each 20 Gy segment. Each 20 Gy segment to be given in 2 Gy fractions over 2 weeks. Chemotherapy with 5-fluorouracil to be administered intravenously on each of the first 3 days of each 20 Gy segment of radiotherapy.
2. Arm B: Systemic therapy with folinic acid followed by 5-fluorouracil to be given on 5 consecutive days every 28 days for six cycles
3. Arm C: Radiotherapy, a split course of 40 Gy with a 2 week separation between each 20 Gy segment. Each 20 Gy segment to be given in 2 Gy fractions over 2 weeks. Radiotherapy to be followed by systemic therapy with folinic acid and 5-fluorouracil to be given on 5 consecutive days every 28 days for six cycles.
4. Arm D: Control, no further treatment
Intervention type
Drug
Phase
Not Specified
Drug names
Adjuvant therapy
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
20/04/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven adenocarcinoma of the pancreas, macroscopically resected. (Patients with pancreatic cystadenocarcinoma and endocrine tumours, tumours of the pancreas and tumours of the duodenum, ampulla of Vater and lower common bile duct are excluded).
2. No evidence of ascities, metastases to the liver, spread to other distant abdominal organs, peritoneal or omental seedlings, or distant metastases
3. Fully recovered from the operation, fit to take part in the trial and life expectancy of more than 3 months
4. No previous or concurrent malignancy diagnosed, except basal cell carcinoma of skin or carcinoma in situ of cervix
5. No serious medical or psychological condition precluding adjuvant treatment
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
20/04/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
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
2001 results in: http://www.ncbi.nlm.nih.gov/pubmed/11716884
Publication citations
-
Results
Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW, , Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial., Lancet, 2001, 358, 9293, 1576-1585.