Clinical trial · Interventional
SBRT Pre-operatively for Pancreatic Cancer
A Phase I Trial of Pre-operative, Margin Intensive, Stereotactic Body Radiation Therapy for Pancreatic Cancer
NCT02308722CI-TRIAL-00054341SPARCcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study the investigators are testing if the addition of Stereotactic Body Radiation therapy (SBRT) prior to surgery improves surgical outcome in patients with borderline resectable or resectable pancreatic cancer (BRPC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fraction stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-fraction stereotactic body radiation therapy
- description
- See intervention
- interventionNames
- Radiation: 5-fraction stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 30 days from SBRT day 1
- description
- The maximum tolerated dose (MTD) is defined as the highest dose of margin-intensive SBRT delivered pre-operatively at which no more than 1 of 6 patients or 0 of 3 patients experiences a dose limiting toxicity (DLT)
Secondary outcomes (5)
- measure
- Definitive resection rate
- timeFrame
- Surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTHolyoake DLP, Robinson M, Silva M, Grose D, McIntosh D, Sebag-Montefiore D, Radhakrishna G, Mukherjee S, Hawkins MA. SPARC, a phase-I trial of pre-operative, margin intensified, stereotactic body radiation therapy for pancreatic cancer. Radiother Oncol. 2021 Feb;155:278-284. doi: 10.1016/j.radonc.2020.11.007. Epub 2020 Nov 18. PMID 33217498
- DERIVEDHolyoake DL, Robinson M, Grose D, McIntosh D, Sebag-Montefiore D, Radhakrishna G, Patel N, Partridge M, Mukherjee S, Hawkins MA. Conformity analysis to demonstrate reproducibility of target volumes for Margin-Intense Stereotactic Radiotherapy for borderline-resectable pancreatic cancer. Radiother Oncol. 2016 Oct;121(1):86-91. doi: 10.1016/j.radonc.2016.08.001. Epub 2016 Aug 9. PMID 27519585