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Pancreatic NeoplasmsPhase 1SPARCNCT02308722

SBRT Pre-operatively for Pancreatic Cancer

A Phase 1 study testing 5-fraction stereotactic body radiation therapy in people with Pancreatic Neoplasms, run by University of Oxford at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
5-fraction stereotactic body radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesUnited Kingdom
Study dates
Apr 2015to Feb 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Borderline resectable localised tumour of the pancreatic head/uncinate process/body as per NCCN Guidelines (tumours of the tail of pancreas are not eligible for inclusion) or operable tumour in contact with vein (SMV or PV) not causing distortion or narrowing as defined by CT +/- MRI +/- PET criteria within 28+/- 7 days prior to trial entry de novo or following chemotherapy.
  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • The Beatson West of Scotland Cancer Centre

    Glasgow

  • St James' Hospital

    Leeds

  • Northern Centre for Cancer Care, The Freeman Hospital

    Newcastle

  • City Hospital

    Nottingham

  • The Churchill Hospital, Oxford University Hospitals Trust

    Oxford

Other trials in United Kingdom

About this study

Official title: A Phase I Trial of Pre-operative, Margin Intensive, Stereotactic Body Radiation Therapy for Pancreatic Cancer

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).

Read the 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.

Being tested
5-fraction stereotactic body radiation therapy
Keywords
Borderline resectable
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT02308722
Study groupRoleWhat they receive
5-fraction stereotactic body radiation therapyExperimentalSee intervention
Receives: Radiation: 5-fraction stereotactic body radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 days from SBRT day 1

Secondary outcomes (5)

  1. Definitive resection rate

    Measured: Surgery

  2. R0/R1/R2 resection margin rates

    Measured: Pathological specimen evaluated at surgery

  3. Rate of pathological complete response

    Measured: Pathological specimen evaluation post operation

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

    Measured: >1 month to 6 months post-surgery

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

    Measured: 12 and 24m FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308722
Sponsor's protocol ID
OCTO_054
Other IDs
18496, 14138956
Acronym
SPARC
Status last verified
Apr 2017
First submitted
2 Dec 2014
Last updated
7 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33217498

  • 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.

    PubMed 27519585

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5-fraction stereotactic body radiation therapy in people with Pancreatic Neoplasms, run by University of Oxford at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 30 days from SBRT day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308722, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.

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