Condition category
Cancer
Date applied
18/03/2015
Date assigned
19/03/2015
Last edited
14/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mrs Elizabeth Ward

ORCID ID

Contact details

Department of Oncology
Oncology Clinical Trials Office (OCTO)
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
Oxford
OX3 7DQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02308722

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Intervention

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

Other

Phase

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

01/11/2014

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

17/04/2015

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Oxford
OX3 9DU
United Kingdom

Trial participating centre

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

Trial participating centre

Leeds Cancer Centre
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

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
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

https://www.admin.ox.ac.uk/researchsupport/ctrg/

Funders

Funder type

Government

Funder name

Cancer Research 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

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

31/01/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27619800

Publication citations

Additional files

Editorial Notes

14/09/2016: Publication reference added.