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SBRT Pre-operatively for Pancreatic Cancer

NCT02308722 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-07

No results posted yet for this study

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).

Conditions

  • Pancreatic Neoplasms

Interventions

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. Level -1: Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV\_R) 8Gy/# (total dose 40Gy) Level 1: Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV\_R) 9Gy/# (total dose 45Gy) Level 2: Tumour (PTV) 6.5Gy/# (total dose 32.5Gy). Area at risk of R1 (PTV\_R) 9.5Gy/# (total dose 47.5Gy) Level 3: Tumour (PTV) 7Gy/# (total dose 35Gy). Area at risk of R1 (PTV\_R) 10Gy/# (total dose 50Gy)

Sponsors & Collaborators

  • Oncology Clinical Trials Office

    collaborator UNKNOWN

  • Centre for Statistics in Medicine

    collaborator OTHER

  • CRUK/MRC Oxford Institute for Radiation Oncology

    collaborator UNKNOWN

  • University of Leeds

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Prof. Maria A Hawkins, MD FRCR MRCP · University of Oxford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308722 on ClinicalTrials.gov