| Source of record | UK Trials |
| ISRCTN | ISRCTN21587955 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | ESPAC-1 |
| Public title | Randomised trial of adjuvant therapy in operable pancreatic cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer of pancreas |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom and Europe |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1995 |
| Anticipated end date | 20/04/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN21587955 |
| Date last extracted from ISRCTN register | 17/04/2008 |
