SBRT Pre-operatively for Pancreatic Cancer (SPARC)

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Borderline resectable Read More

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.

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. PPregnancy. 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.