Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01097239
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

Objective: A single centre pilot Phase I/II trial to establish the feasibility of transrectal HIFU as an additional option treatment modality in patients with locally advanced pelvic rectal cancer that is either primary or recurrent and for whom all available current therapy is inappropriate and/or exhausted.

We shall make a preliminary assessment of safety & dosage for later evaluation in a randomised controlled trial. Whilst efficacy data are limited in a small feasibility study; radiological and biochemical analyses of the patient and histopathological analysis of patient specimens together with specific validated symptom and quality of life questionnaires (QoL), will be used to provide surrogate preliminary measures in this patient cohort.

Hypothesis: HIFU is safe and will improve patient symptoms and QoL where no alternative contemporary therapies are available.


Condition Intervention Phase
Rectal Cancer
Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase I/II Feasibility/Efficacy Study of HIFU in Otherwise Untreatable Pelvic Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Quality of life scores (EORTC QLQ−C30 and EORTC QLQ−CR38) [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]
    Validated Quality of Life Questionnaire


Secondary Outcome Measures:
  • Pain relief visual analogue scale [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]
  • Tumour marker changes (CEA and CA19.9) [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Focused Ultrasound
Transrectal High Intensity Focused Ultrasound (HIFU) treatment of the Rectal Tumour
Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))
High Intensity Focused Ultrasound (HIFU) Delivered by the Sonablate 500 Transrectal Device
Other Names:
  • Sonablate 500
  • HIFU

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Biopsy proven cancer of the rectum (tumour <15cm from anal verge)
  • Partially fixed/unresectable disease and locally advanced disease (T3/T4)
  • Patient considered to be unsuitable for or have exhausted all currently available therapies
  • WHO Performance Status 0-2
  • Fit for general anaesthetic and HIFU
  • Not pregnant
  • No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment
  • Written informed consent for treatment

Exclusion Criteria:

  • WHO performance status of 3 or more
  • Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent
  • Pelvic sepsis
  • Currently enrolled in any other treatment trial
  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: NCT01097239

Contacts
Contact: Paul D Abel, ChM FRCS(Lon) FRCS(Ed) +44208 383 2268 p.abel@imperial.ac.uk
Contact: Leonardo Monzon, BSc MBBS MRCS(Eng) +447932043627 leonardomonzonrodriguez@googlemail.com

Locations
United Kingdom
Imperial College Healthcare NHS Trust (Hammersmith Hospital) Recruiting
London, England, United Kingdom, W12 0HS
Contact: Paul D Abel, ChM FRCS(Lon) FRCS(Ed)    +44208 383 2268    p.abel@imperial.ac.uk   
Contact: Leonardo Monzon, BSc MBBS MRCS(Eng)    +447932043627    leonardomonzonrodriguez@googlemail.com   
Principal Investigator: Paul D Abel, ChM FRCS(Lon) FRCS(Ed)         
Sub-Investigator: Edward Leen, MD FRCR         
Sub-Investigator: Peter Dawson, FRCS         
Sub-Investigator: Chris Harvey, FRCR         
Sub-Investigator: Harpreet Wasan, MBBS MRCP         
Sub-Investigator: Hashim U Ahmed, MRCS         
Sub-Investigator: Leonardo Monzon, BSc MBBS MRCS(Eng)         
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: Paul D Abel, ChM FRCS(Lon) FRCS(Ed) Imperial College London
Study Chair: Leonardo Monzon, BSc MBBS MRCS(Eng) Imperial College Healthcare NHS Trust
  More Information

Additional Information:
Publications:

Responsible Party: Professor Paul David Abel, Imperial College London
ClinicalTrials.gov Identifier: NCT01097239     History of Changes
Other Study ID Numbers: 09/H0808/43
Study First Received: March 31, 2010
Last Updated: March 31, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
High Intensity Focused Ultrasound
HIFU
Rectal Cancer
Sonablate 500
Transrectal

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

ClinicalTrials.gov processed this record on September 18, 2014