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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic ablative radiotherapy (SABR) | Other | Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative stereotactic ablative body radiotherapy | Radiation | Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days. | Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery | Up to 30days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of surgical resection margin status following pre-operative SABR and immediate surgery | Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report | Post surgery |
| Measure of local control post SABR and surgery |
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Inclusion Criteria Stage 1:
Inclusion Criteria Stage 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thankamma Ajithkumar | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrookes Hospital | Cambridge | Cb2 0QQ | United Kingdom |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Number of patients with local control from CT scans up to 12months from the start of SABR |
| 1 year |
| Measure of disease-free survival post SABR and surgery | Number of patients with disease progression from CT scans up to 12months from the start of SABR | 1 year |
| Measure of overall survival post SABR and surgery | Number of deaths up to 12 months from the start of SABR treatment | 1 year |
| Acute and late toxicity of pre-operative SABR: Number of adverse events | Number of adverse events reported up to 12 months from the start of SABR treatment | 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |