Ignite Creation Date:
2024-05-06 @ 3:30 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02308722
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2014-12-02
Brief Title:
SBRT Pre-operatively for Pancreatic Cancer
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase I Trial of Pre-operative Margin Intensive Stereotactic Body Radiation Therapy for Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief Summary:
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
Detailed Description:
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
Surgical resection is the only potentially curative technique for managing pancreatic cancer However more than 80 of patients present with disease that cannot be cured with surgical resection Negative margin R0 resection tumour size absence of lymph nodes metastases are the strongest prognostic indicators for long term survival
Stereotactic body radiation therapy SBRT is a radiation technique for pancreatic cancer where an ablative dose of radiotherapy RT can be delivered to a small volume targeting the at risk surgical margin in a short time 1 week versus 5-6 weeks for standard radiotherapy achieving much higher biologically equivalent dose BED 100Gy versus 50Gy than conventionally fractionated radical RT The short time of delivery and minimal acute toxicity makes this an attractive treatment option in BPRC as offers the opportunity to integrate systemic treatment With standard fractionation schedules larger volumes of normal tissue are usually irradiated than with SBRT and an effective dose is limited by toxicity despite the use of Intensity Modulated RT
This study builds on the current evidence base in SBRT pancreas which has so far been largely used in the locally advanced setting with promising results and aims to take it a step further This study aims to test the safety and benefit of pre-operative SBRT delivering very high local doses to the at risk surgical margin which is usually around the main vessels in the retroperitoneum The concept of margin-intensive therapy is novel and aims to deliver a higher radiation dose while limiting toxicity to organs at risk
Surgical resection is the only potentially curative technique for managing pancreatic cancer However more than 80 of patients present with disease that cannot be cured with surgical resection Negative margin R0 resection tumour size absence of lymph nodes metastases are the strongest prognostic indicators for long term survival
Stereotactic body radiation therapy SBRT is a radiation technique for pancreatic cancer where an ablative dose of radiotherapy RT can be delivered to a small volume targeting the at risk surgical margin in a short time 1 week versus 5-6 weeks for standard radiotherapy achieving much higher biologically equivalent dose BED 100Gy versus 50Gy than conventionally fractionated radical RT The short time of delivery and minimal acute toxicity makes this an attractive treatment option in BPRC as offers the opportunity to integrate systemic treatment With standard fractionation schedules larger volumes of normal tissue are usually irradiated than with SBRT and an effective dose is limited by toxicity despite the use of Intensity Modulated RT
This study builds on the current evidence base in SBRT pancreas which has so far been largely used in the locally advanced setting with promising results and aims to take it a step further This study aims to test the safety and benefit of pre-operative SBRT delivering very high local doses to the at risk surgical margin which is usually around the main vessels in the retroperitoneum The concept of margin-intensive therapy is novel and aims to deliver a higher radiation dose while limiting toxicity to organs at risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18496 | OTHER | None | None |
| 14138956 | REGISTRY | ISRCTN | None |