PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases (PERFORM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01410760
First received: August 3, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.


Condition Intervention Phase
Metastatic Colorectal Cancer
Other: Perfusion CT scan
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Perfusion Computed Tomography Pilot Study in the NCRN FOXFIRE Clinical Trial to Determine Blood Flow to Liver Metastases

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Recruitment rate to this voluntary study and acquisition of sufficient data for perfusion analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between the tumour perfusion pattern on perfusion CT studies at baseline and shortly after the start of therapy and morphological response by RECIST criteria on CT scan 3 months post therapy in both arms of the FOXFIRE trial. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Perfusion CT scan
    Patients in this imaging substudy of the FOXFIRE clinical trial will undergo a perfusion CT prior to FOXFIRE protocol therapy( Ox/MDG chemo alone for 12 cycles in arm A or OX+MDG chemo for 12 cycles with Yttrium 90 SIRshpheres liver radioembolisaton in arm B cycle 2) on Day 1/2 cycle 2, Day 1/2 cycle 3 and Day 1/2 cycle 5 chemotherapy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have given written informed consent to participate in the FOXFIRE clinical trial and have not yet started chemotherapy treatment in the trial.
  • Serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (ULN) in blood tests performed up to 29 days before entry into the FOXFIRE clinical trial.
  • Liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the FOXFIRE clinical trial

Exclusion Criteria:

  • True allergy to intravenous iodinated CT contrast
  • Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410760

Contacts
Contact: Ricky A Sharma, MBBChir 01865 617322 Ricky.Sharma@oncology.ox.ac.uk

Locations
United Kingdom
Oxford Radcliffe Hospitals NHS Trust Recruiting
Oxford, United Kingdom, OX3 7LJ
Contact: Ricky A Sharma, MB BChir    01865 617322    ricky.sharma@oncology.ox.ac.uk   
Sub-Investigator: Esme J Hill, MBChB         
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
University Hospitals, Leicester
Investigators
Principal Investigator: Ricky A Sharma, MB BChir University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01410760     History of Changes
Other Study ID Numbers: 10/H0505/95
Study First Received: August 3, 2011
Last Updated: June 19, 2012
Health Authority: UK: National Research Ethics Service

Keywords provided by University of Oxford:
Imaging study
Perfusion Computerised Tomography

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014