Title

SPARC

Chief Investigator: 

​Sponsor: University of Oxford
ClinicalTrials.gov Number: NCT02308722
UKCRN ID: 18496

Stereotactic Body Radiotherapy (SBRT) pre-operatively for pancreatic cancer: A Phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy for pancreatic cancer.

Study Design

Phase I rolling six design dose escalation study testing the use of Stereotactic Body Radiation Therapy (SBRT) delivered in the pre-operative setting for pancreatic cancers.

Study Population

Patients with borderline resectable or resectable localised tumour of the pancreatic head/uncinated process/body as defined by CT +/- MRI +/- PET criteria within 28 +/-7 days prior to trial entry.

Study Status

Open to recruitment

Target recruitment: maximum of 24 evaluable patients

Current Recruitment: 6 patients (September 2016)

Sites

Open to recruitment: 5

  • Churchill Hospital, Oxford University Hospitals Trust
  • The Beatson West of Scotland Cancer Centre, NHS Great Glasgow and Clyde
  • Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust
  • Nottingham Cancer Centre, Nottingham University Hospitals NHS Trust
  • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Study Schema

 

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) or operable tumour in contact with vein (SMV or PV) not causing distortion or narrowing 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.
  8. ECOG performance status 0-1
  9. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
  10. Written (signed and dated) informed consent and be capable of co-operating with protocol.
  11. Haematological and biochemical indices within defined ranges shown below:
Lab Test Value Required
Haemaglobin (Hb) ≥ 9.0 g/dL
White Blood Count (WBC) > 3 x 109/l
Platelet count >100 x 109/l
Neutrophils > 1.5 x 109/l
Serum bilirubin < 60 μmol/l
ALT and/ or AST ≤3.0 times ULN

 

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 for which the expected prognosis is likely to be worse than that for 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 right chest wall radiotherapy where 30% of the liver has received >15Gy.
  5. Pregnancy. Pregnant or breast-feeding women are ineligible. Women of childbearing potential must use effective methods of contraception.
  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.

Primary Objectives

  • To establish the maximum tolerated dose (MTD) of margin-intensive SBRT delivered pre-operatively in the management of pancreatic cancer

Secondary Objectives:

  • To examine key clinical outcomes for patients treated with this regimen, namely:
    • Surgical resection rates
    • Resection margin status
    • Response rates
  • Late SBRT toxicity (>1 month to 6 months post-surgery or to 6 months post SBRT for patients not proceeding to surgery)
  • Efficacy and long term safety of SBRT delivered pre-operatively in the management of pancreatic cancer

Tertiary/Exploratory Objectives:

  • To investigate if a relationship between imaging and pathology can be established
  • To explore possible immune-related responses to SBRT in pancreatic cancer

Key Dates

First site open to recruitment: 17 April 2015
Planned accrual completion: 17 April 2017
Trial duration: 39 months

Data Submission

Data submission for this trial is via electronic submission of data in OpenClinica

SPARC Trial Office (OCTO)

SPARC Trial Office: Tel: +44 (0)1865 617078
SPARC Registration Service Mon-Fri 9-5 (UK Time): UK Fax: +44(0)1865 617010
General Enquiries: Tel: +44 (0)1865 227 177
Fax: +44(0)1865 617010 
Website: http://www.oncology.ox.ac.uk/research/oncology-clinical-trials-office-octo
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