Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Contact information



Primary contact

Mrs Elizabeth Ward


Contact details

Department of Oncology
Oncology Clinical Trials Office (OCTO)
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number

OCTO_054; 18496

Study information

Scientific title

A Phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy for previously untreated borderline resectable pancreatic cancer


SPARC: SBRT pre-operatively for borderline resectable pancreatic cancer

Study hypothesis

This study aims to test the safety and efficacy of pre-operative stereotactic body radiation therapy (SBRT), and to establish the maximum tolerated dose (MTD) of margin-intensive SBRT delivered pre-operatively in the surgical management of pancreatic cancer.

Ethics approval

NRES Committee South Central Oxford B, ref: 15/SC/0059

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Pancreas


This is a single arm prospective phase I dose escalation radiation study investigating 5-fraction stereotactic radiotherapy prior to planned surgical resection in borderline resectable pancreatic cancer.
If we achieve the MTD then we will recruit up to 24 patients from 3 UK centres (Oxford, Leeds and Glasgow). Eligible patients will receive 5 fractions of stereotactic radiotherapy over 5-8 days, and surgery will take place 5-6 weeks after radiotherapy. Patients will be on the study for approximately 36 weeks from registration on the study to the end of treatment visit (last protocol visit).

Intervention type



Phase I

Drug names

Primary outcome measures

Maximum Tolerated Dose (MTD); Timepoint(s): 30 days post-surgery

Secondary outcome measures

1. Resection rates: Definitive resection rate. Time point (s) of evaluation of this end point - surgery
2. Resection margin status: R0/R1/R2 resection margin rates. Time point (s) of evaluation of this end point - pathological specimen evaluated at surgery
3. Response rates: Rate of pathological complete response. Time point (s) of evaluation of this end point - pathological specimen evaluation post operation
4. Late SBRT toxicity (>1 month to 6 months post-surgery): Any Late GI AE/other AE > grade 2 CTCAE v4.03. Time point (s) of evaluation of this end point - post-surgery visits > 1month, 3 months and 6 months
5. Efficacy and long term safety of SBRT delivered pre-operatively in the management of pancreatic cancer: Overall survival and progression free survival at 12 and 24 months post D1 SBRT. Time point (s) of evaluation of this end point -12 and 24m FU
6. To investigate if a relationship between imaging and pathology can be established: Differences between R0 as predicted by CT + MRI + PET pre-SBRT, post-SBRT and pathology findings. Time point (s) of evaluation of this end point - post-surgery
7. To explore possible immune-related responses to SBRT in pancreatic cancer: Changes in levels of interferon-related RNA and cytological markers of the innate and adaptive immune response before and during SBRT in pancreatic cancer. Time point (s) of evaluation of this end point - before, during and after SBRT

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Borderline resectable localised tumour of the pancreatic head/uncinate process/body as per NCCN Guidelines (tumours of the tail of pancreas are not eligible for inclusion) as defined by CT +/MRI +/PET criteria within 28+/7 days prior to trial entry
2. Histologically proven pancreatic ductal adenocarcinoma or cytological proven pancreatic malignancy
3. Able to undergo biliary drainage using a stent
4. Deemed fit and suitable for surgical resection
5. Male or female, Age = 16 years
6. Life expectancy of at least 6 months
7. ECOG performance status 0-1
8. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled followup visits and examinations
9. Written (signed and dated) informed consent and be capable of cooperating with protocol
10. Haematological and biochemical indices within given ranges

Participant type


Age group




Target number of participants

Planned Sample Size: 24; UK Sample Size: 24

Participant exclusion criteria

1. Distant metastatic disease or local disease that cannot be encompassed in the SBRT field
2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix; curatively treated cancer of other sites who are recurrence free for ≥ 3 years)
3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection
4. Previous upper abdominal or chest wall radiotherapy
5. Pregnancy. Pregnant or breastfeeding women or women of childbearing potential unless effective methods of contraception are used
6. Any other psychological, social or medical condition, physical examination finding or laboratory abnormality that the Investigator considers makes the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of the trial results.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
United Kingdom

Trial participating centre

The Beatson West of Scotland Cancer Centre
G12 0YN
United Kingdom

Trial participating centre

Leeds Cancer Centre
United Kingdom

Sponsor information


University of Oxford

Sponsor details

c/o Ms Heather House
University of Oxford Clinical Trials and Research Governance Team
Joint Research Office Block 60
Churchill Hospital
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Data from all sites will be analysed together and published as soon as possible. Individual participating PIs may not publish data concerning their participants which are directly relevant to questions posed by the trial until the TMG has published its report. The TMG will form the basis of the writing committee and advise on the nature of publications, subject to the Sponsor’s requirements.

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in:

Publication citations

Additional files

Editorial Notes

14/09/2016: Publication reference added.