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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Thuroff S, Chaussy C, Vallancien G, Wieland W, Kiel HJ, Le Duc A, Desgrandchamps F, De La Rosette JJ, Gelet A. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol. 2003 Oct;17(8):673-7.

Hill CR, ter Haar GR. Review article: high intensity focused ultrasound--potential for cancer treatment. Br J Radiol. 1995 Dec;68(816):1296-1303. Review.

Thüroff S, Chaussy C. High-intensity focused ultrasound: complications and adverse events. Mol Urol. 2000 Fall;4(3):183-7;discussion 189.

Visioli AG, Rivens IH, ter Haar GR, Horwich A, Huddart RA, Moskovic E, Padhani A, Glees J. Preliminary results of a phase I dose escalation clinical trial using focused ultrasound in the treatment of localised tumours. Eur J Ultrasound. 1999 Mar;9(1):11-8.

Wu F, Chen WZ, Bai J, Zou JZ, Wang ZL, Zhu H, Wang ZB. Pathological changes in human malignant carcinoma treated with high-intensity focused ultrasound. Ultrasound Med Biol. 2001 Aug;27(8):1099-106.

Wu F, Wang ZB, Chen WZ, Bai J, Zhu H, Qiao TY. Preliminary experience using high intensity focused ultrasound for the treatment of patients with advanced stage renal malignancy. J Urol. 2003 Dec;170(6 Pt 1):2237-40.

Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54.

Blana A, Walter B, Rogenhofer S, Wieland WF. High-intensity focused ultrasound for the treatment of localized prostate cancer: 5-year experience. Urology. 2004 Feb;63(2):297-300. Review.

Gelet A, Chapelon JY, Poissonnier L, Bouvier R, Rouvière O, Curiel L, Janier M, Vallancien G. Local recurrence of prostate cancer after external beam radiotherapy: early experience of salvage therapy using high-intensity focused ultrasonography. Urology. 2004 Apr;63(4):625-9.

Wu F, Wang ZB, Cao YD, Chen WZ, Bai J, Zou JZ, Zhu H. A randomised clinical trial of high-intensity focused ultrasound ablation for the treatment of patients with localised breast cancer. Br J Cancer. 2003 Dec 15;89(12):2227-33.

Moore WE, Lopez RM, Matthews DE, Sheets PW, Etchison MR, Hurwitz AS, Chalian AA, Fry FJ, Vane DW, Grosfeld JL. Evaluation of high-intensity therapeutic ultrasound irradiation in the treatment of experimental hepatoma. J Pediatr Surg. 1989 Jan;24(1):30-3; discussion 33.

Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10.

Beets-Tan RG, Beets GL, Vliegen RF, Kessels AG, Van Boven H, De Bruine A, von Meyenfeldt MF, Baeten CG, van Engelshoven JM. Accuracy of magnetic resonance imaging in prediction of tumour-free resection margin in rectal cancer surgery. Lancet. 2001 Feb 17;357(9255):497-504.

Quirke P, Durdey P, Dixon MF, Williams NS. Local recurrence of rectal adenocarcinoma due to inadequate surgical resection. Histopathological study of lateral tumour spread and surgical excision. Lancet. 1986 Nov 1;2(8514):996-9.

Fazio VW, Tekkis PP, Remzi F, Lavery IC. Assessment of operative risk in colorectal cancer surgery: the Cleveland Clinic Foundation colorectal cancer model. Dis Colon Rectum. 2004 Dec;47(12):2015-24.

Buess G, Mentges B, Manncke K, Starlinger M, Becker HD. Technique and results of transanal endoscopic microsurgery in early rectal cancer. Am J Surg. 1992 Jan;163(1):63-9; discussion 69-70.

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 May 16, 2013

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