NCT02308722

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 7, 2021

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

December 2, 2014

Last Update Submit

September 29, 2021

Conditions

Pancreatic Neoplasms

Keywords

Borderline resectable

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    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)

    30 days from SBRT day 1

Secondary Outcomes (5)

  • Definitive resection rate

    Surgery

  • R0/R1/R2 resection margin rates

    Pathological specimen evaluated at surgery

  • Rate of pathological complete response

    Pathological specimen evaluation post operation

  • Any Late GI AE/other AE > grade 2 CTCAE v4.03

    >1 month to 6 months post-surgery

  • Overall survival and progression free survival at 12 and 24 months post D1 SBRT

    12 and 24m FU

Study Arms (1)

5-fraction stereotactic body radiation therapy

EXPERIMENTAL

See intervention

Radiation: 5-fraction stereotactic body radiation therapy

Interventions

5-fraction stereotactic body radiation therapyRADIATION

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)

5-fraction stereotactic body radiation therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven pancreatic ductal adenocarcinoma or cytological proven pancreatic malignancy.
  • Able to undergo biliary drainage using a stent.
  • Deemed fit and suitable for surgical resection.
  • No overt metastases or uncertain status with investigations suspicious of possible metastatic disease (e.g. small equivocal pulmonary nodule(s)).
  • Male or female, Age \>= 16 years.
  • Life expectancy of at least 6 months.
  • ECOG performance status 0- 1
  • The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
  • Written (signed and dated) informed consent and be capable of co-operating with protocol.
  • Haematological and biochemical indices within defined ranges.

You may not qualify if:

  • Distant metastatic disease or local disease that cannot be encompassed in the SBRT field.
  • 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).
  • Serious medical or psychological condition precluding trial intervention.
  • Previous upper abdominal or right chest wall radiotherapy where 30% of the liver has received \>15Gy.
  • PPregnancy. Pregnant or breast-feeding women are ineligible. Women of childbearing potential must use effective methods of contraception.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

St James' Hospital

Leeds, United Kingdom

Location

Northern Centre for Cancer Care, The Freeman Hospital

Newcastle, United Kingdom

Location

City Hospital

Nottingham, United Kingdom

Location

The Churchill Hospital, Oxford University Hospitals Trust

Oxford, United Kingdom

Location

Related Publications (2)

  • Holyoake 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: 33217498RESULT

  • Holyoake 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: 27519585DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Prof. Maria A Hawkins, MD FRCR MRCP

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

April 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

October 7, 2021

Record last verified: 2017-04

Locations

GB(5)