Randomised trial of adjuvant therapy in operable pancreatic cancer

ISRCTN ISRCTN21587955
DOI https://doi.org/10.1186/ISRCTN21587955
Secondary identifying numbers ESPAC-1
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
14/07/2014
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 of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer of pancreas
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Adjuvant therapy
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date20/04/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment20/04/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/11/2001 Yes No