SBRT Pre-operatively for Pancreatic Cancer (SPARC)
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|ClinicalTrials.gov Identifier: NCT02308722|
Recruitment Status : Unknown
Verified April 2017 by University of Oxford.
Recruitment status was: Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Radiation: 5-fraction stereotactic body radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Pre-operative, Margin Intensive, Stereotactic Body Radiation Therapy for Pancreatic Cancer|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||February 2019|
Experimental: 5-fraction stereotactic body radiation therapy
Radiation: 5-fraction stereotactic body radiation therapy
The investigators expect to need a maximum of 3 dose levels investigating dose to the area at risk of involved resection lines and to the tumour bed to assess the tolerability of SBRT in this setting.
Patient entry will commence at level 1. There is the option to de-escalate to Level -1 should 2 or more DLTs be observed at the starting level. SBRT will not be escalated above level 3.
Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV_R) 8Gy/# (total dose 40Gy)
Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV_R) 9Gy/# (total dose 45Gy)
Tumour (PTV) 6.5Gy/# (total dose 32.5Gy). Area at risk of R1 (PTV_R) 9.5Gy/# (total dose 47.5Gy)
Tumour (PTV) 7Gy/# (total dose 35Gy). Area at risk of R1 (PTV_R) 10Gy/# (total dose 50Gy)
- Maximum tolerated dose (MTD) [ Time Frame: 30 days from SBRT day 1 ]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)
- Definitive resection rate [ Time Frame: Surgery ]
- R0/R1/R2 resection margin rates [ Time Frame: Pathological specimen evaluated at surgery ]
- Rate of pathological complete response [ Time Frame: Pathological specimen evaluation post operation ]
- Any Late GI AE/other AE > grade 2 CTCAE v4.03 [ Time Frame: >1 month to 6 months post-surgery ]
- Overall survival and progression free survival at 12 and 24 months post D1 SBRT [ Time Frame: 12 and 24m FU ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308722
|The Beatson West of Scotland Cancer Centre|
|Glasgow, United Kingdom|
|St James' Hospital|
|Leeds, United Kingdom|
|Northern Centre for Cancer Care, The Freeman Hospital|
|Newcastle, United Kingdom|
|Nottingham, United Kingdom|
|The Churchill Hospital, Oxford University Hospitals Trust|
|Oxford, United Kingdom|
|Principal Investigator:||Prof. Maria A Hawkins, MD FRCR MRCP||University of Oxford|