SBRT Pre-operatively for Pancreatic Cancer (SPARC)

September 29, 2021 updated by: University of Oxford

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • The Beatson West of Scotland Cancer Centre
      • Leeds, United Kingdom
        • St James' Hospital
      • Newcastle, United Kingdom
        • Northern Centre for Cancer Care, The Freeman Hospital
      • Nottingham, United Kingdom
        • City Hospital
      • Oxford, United Kingdom
        • The Churchill Hospital, Oxford University Hospitals Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Distant metastatic disease or local disease that cannot be encompassed in the SBRT field.
  2. 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).
  3. Serious medical or psychological condition precluding trial intervention.
  4. Previous upper abdominal or right chest wall radiotherapy where 30% of the liver has received >15Gy.
  5. PPregnancy. Pregnant or breast-feeding women are ineligible. Women of childbearing potential must use effective methods of contraception.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 5-fraction stereotactic body radiation therapy
See intervention
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days from SBRT day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Definitive resection rate
Time Frame: Surgery
Surgery
R0/R1/R2 resection margin rates
Time Frame: Pathological specimen evaluated at surgery
Pathological specimen evaluated at surgery
Rate of pathological complete response
Time Frame: Pathological specimen evaluation post operation
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
>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
12 and 24m FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Leeds
Centre for Statistics in Medicine
Oncology Clinical Trials Office
CRUK/MRC Oxford Institute for Radiation Oncology

Investigators

  • Principal Investigator: Prof. Maria A Hawkins, MD FRCR MRCP, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (ESTIMATE)

December 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCTO_054
  • 18496 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • 14138956 (REGISTRY: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on 5-fraction stereotactic body radiation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe