Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

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

  1. 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.

Additional files

Editorial Notes