Condition category
Cancer
Date applied
18/03/2015
Date assigned
19/03/2015
Last edited
10/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer 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

Type

Public

Additional contact

Ms Stephanie Levy

ORCID ID

Contact details

Oncology Clinical Trials Office (OCTO)
Department of Oncology
University of Oxford
Old Road Campus
Roosevelt Drive
Oxford
OX3 7DQ
United Kingdom
+44 (0)1865 617084
stephanie.levy@oncology.ox.ac.uk

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 pancreatic cancer

Acronym

SPARC: SBRT pre-operatively for 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

Current interventions as of 10/05/2018:
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 or resectable pancreatic cancer. If we achieve the MTD then we will recruit up to 24 patients from 5 UK centres (Oxford, Leeds, Glasgow, Nottingham and Newcastle). Eligible patients will receive 5 fractions of stereotactic radiotherapy over 5-8 days, and surgery, if appropriate, 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).

Previous interventions:
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

Current primary outcome measure as of 10/05/2018:
Maximum Tolerated Dose (MTD); Timepoint(s): 30 days post-surgery for patients proceeding to surgery or 3 months post SBRT for patients not proceeding to surgery.

Previous primary outcome measure:
Maximum Tolerated Dose (MTD); Timepoint(s): 30 days post-surgery

Secondary outcome measures

Current secondary outcome measures as of 10/05/2018:
1. Resection rates: Definitive resection rate. Timepoint(s) of evaluation of this end point - surgery
2. Resection margin status: R0/R1/R2 resection margin rates. Timepoint(s) of evaluation of this end point - pathological specimen evaluated at surgery
3. Response rates: Rate of pathological complete response. Timepoint(s) of evaluation of this end point - pathological specimen evaluation post operation
4. Late SBRT toxicity (>1 month to 6 months post-surgery or to 6 months post SBRT for patients not proceeding to surgery): Any Late GI AE/other AE > grade 2 CTCAE v4.03. Timepoint(s) of evaluation of this end point - post-surgery visits >1 month, 3 months and 6 months or 3 and 6 months post-SBRT for patients not proceeding to surgery
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. Timepoint(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. Timepoint(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. Timepoint(s) of evaluation of this end point - before, during and after SBRT

Previous secondary outcome measures:
1. Resection rates: Definitive resection rate. Timepoint(s) of evaluation of this end point - surgery
2. Resection margin status: R0/R1/R2 resection margin rates. Timepoint(s) of evaluation of this end point - pathological specimen evaluated at surgery
3. Response rates: Rate of pathological complete response. Timepoint(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. Timepoint(s) of evaluation of this end point - post-surgery visits >1 month, 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. Timepoint(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. Timepoint(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. Timepoint(s) of evaluation of this end point - before, during and after SBRT

Overall trial start date

01/11/2014

Overall trial end date

01/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Current participant inclusion criteria as of 10/05/2018:
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) or operable tumour in contact with or operable tumour in contact with, as defined by CT +/MRI +/PET criteria within 28+/7 days prior to trial entry de novo or following chemotherapy.
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. No overt metastases or uncertain status with investigations suspicious of possible metastatic disease (e.g. small equivocal pulmonary nodule(s)).
6. Male or female, Age = 16 years
7. 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

Previous 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

Current participant exclusion criteria as of 10/05/2018:
1. Definite metastatic disease or local disease that cannot be encompassed in the SBRT field
2. History of previous or concurrent malignancy diagnoses for which the expected prognosis is likely to be worse than that of the current diagnosis of pancreatic cancer (excludes for example: e.g. localised prostate cancer, early colorectal cancer, early breast cancer, 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 trial intervention
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.

Previous 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

22/03/2018

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

Trial participating centre

Nottingham University Hospitals
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Freeman Hospital
Newcastle
NE7 7DN
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

10/05/2018: The following changes have been made: 1. Stephanie Levy has been added as the primary contact. 2. The scientific title has been changed from "A phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy for previously untreated borderline resectable pancreatic cancer" to "A phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy for pancreatic cancer". 3. The acronym has been changed from "SPARC: SBRT pre-operatively for borderline resectable pancreatic cancer" to "SPARC: SBRT pre-operatively for pancreatic cancer". 4. The interventions have been changed. 5. The primary outcome measure has been changed. 6. The secondary outcome measures have been changed. 7. The overall trial end date has been changed from 31/01/2018 to 01/03/2019. 8. The participant inclusion criteria have been changed. 9. The participant exclusion criteria have been changed. 10. The recruitment end date has been changed from 31/03/2017 to 22/03/2018. 11. Nottingham University Hospitals and Freeman Hospital have been added as trial centres. 14/09/2016: Publication reference added.