Exploring HIFU as a Treatment for Rectal and Other Pelvic Cancers

NCT03595722 | Unknown

• 1 other identifier: 18SM4430
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the study is that high intensity focused ultrasound (HIFU) can be used safely to treat rectal and pelvic cancer. The study consists of two trials exploring the use of HIFU in rectal and pelvic cancer to establish the safety and potential efficacy of HIFU in this instance. The first trial is a feasibility study looking at patients with early rectal cancer. We aim to recruit thirty patients with early rectal cancer who are due to undergo an operation to remove their cancer. After recruiting and consenting them for the trial, we will treat their rectal cancer with HIFU. Approximately one week after treatment they will undergo their normal cancer operation. This will allow us to demonstrate the safety of HIFU as a treatment for rectal cancer and evaluate the changes in rectal and surrounding tissue under the microscope after the cancer is treated with HIFU. In addition, we will monitor patients for any complications and the impact this treatment has on their quality of life. We will monitor the response of various markers for cancer with blood tests. The second trial aims to evaluate the treatment of a cohort of patients with inoperable rectal cancer. We aim to recruit thirty patients with either inoperable pelvic cancers - rectal, cervical or endometrial, or cancers that have returned after previous operations. We will offer these patients treatment of their cancer using HIFU. We will monitor the symptoms they experience and impact on their quality of life both before and at multiple time points after the treatment with HIFU. We will compare MRI scans before and after treatment to evaluate the effect HIFU has in reducing the size of the cancer. We hope to show that using HIFU in this group of patients can be both effective and lead to an improvement in both their symptoms and quality of life.

Conditions

Rectal Cancer; Rectal Neoplasms; Pelvic Cancer; Endometrial Cancer; Cervical Cancer

Keywords

Pelvic cancer; rectal cancer; HIFU; QoL; complications

Outcome Measures

Primary Outcomes (1)

• Complications

  Complications and toxicity of HIFU treatment

  0-30 days

Secondary Outcomes (5)

• Symptom control

  7-90 days

• Histological tissue changes

  7-10 days

• Tumour marker changes

  7-90 days

• Inflammatory marker changes

  7-90 days

• Radiological changes

  30 days

Study Arms (2)

Early rectal cancer

EXPERIMENTAL

Patients with early rectal cancer undergoing a treat and resect pathway - patients will be treated with high intensity focused ultrasound 7-10 days prior to the surgical resection of their rectal cancer

Device: High Intensity Focused Ultrasound

Late pelvic cancer

EXPERIMENTAL

Patients with late pelvic (rectal, endometrial, cervical) cancer will undergo a treat and observe pathway - patients will be treated with high intensity focused ultrasound and their response will be observed

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused Ultrasound DEVICE

High intensity focused ultrasound to rectal/pelvic cancer

Early rectal cancer; Late pelvic cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early rectal cancer arm:
• Biopsy proven rectal cancer \<15cm from anal verge
• Targeted region ≤ 3cm in depth dimension, deepest region of tumour ≤ 3.5cm from organ/tissue surface accessible by the probe
• Tumour accessible by the HIFU probe via suitable acoustic window
• Early stage disease not requiring neo-adjuvant chemo radiotherapy prior to TME - T1/T2 but confirmed to require adjuvant chemotherapy
• Ability to undergo an intraluminal ultrasound examination
• World Health Organisation (WHO) Performance Status 0-3
• Age ≥18 and fit for general anaesthetic and HIFU
• For women of child bearing potential, not pregnant
• No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment
• Written informed consent for treatment
• Late pelvic cancer arm:
• Biopsy proven rectal, vaginal, endometrial or cervical cancer (tumour \<15cm from anal/vaginal verge)
• Solid tumour/mass ≤ 3cm in depth dimension, deepest region of tumour ≤ 3.5cm from organ/tissue surface accessible by the probe
• Lymph node(s) accessible by HIFU for which the primary clinical team advise intervention

You may not qualify if:

• Early rectal cancer arm:
• WHO performance status of 4
• 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 neo-adjuvant treatment trial that may induce tumour regression
• Locally advanced disease - T3/T4 or patients who are not thought to require adjuvant therapy
• Tumours above peritoneal reflection or below dentate line
• Subjects with tumours lying \< 1cm from sensitive structures/organs
• Late pelvic cancer arm:
• WHO performance status of 4
• 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 palliative treatment trial that may confound results
• Subjects with tumours lying \< 1cm from sensitive structures/organs

Sponsors & Collaborators

• Imperial College London: lead
• SonaCare Medical: collaborator

Study Sites (1)

Imperial College London

London, W2 1NY, United Kingdom

RECRUITING

Related Publications (6)

• 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. doi: 10.1089/089277903322518699.

  PMID: 14622488 BACKGROUND

• Hill CR, ter Haar GR. Review article: high intensity focused ultrasound--potential for cancer treatment. Br J Radiol. 1995 Dec;68(816):1296-1303. doi: 10.1259/0007-1285-68-816-1296.

  PMID: 8777589 BACKGROUND

• Gelet A, Chapelon JY, Bouvier R, Souchon R, Pangaud C, Abdelrahim AF, Cathignol D, Dubernard JM. Treatment of prostate cancer with transrectal focused ultrasound: early clinical experience. Eur Urol. 1996;29(2):174-83.

  PMID: 8647143 BACKGROUND

• 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. doi: 10.1097/01.ju.0000097123.34790.70.

  PMID: 14634387 BACKGROUND

• 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. doi: 10.1067/mob.2003.345.

  PMID: 12861137 BACKGROUND

• Monzon L, Wasan H, Leen E, Ahmed H, Dawson PM, Harvey C, Muhamed A, Hand J, Price P, Abel PD. Transrectal high-intensity focused ultrasonography is feasible as a new therapeutic option for advanced recurrent rectal cancer: report on the first case worldwide. Ann R Coll Surg Engl. 2011 Sep;93(6):e119-21. doi: 10.1308/147870811X592458.

  PMID: 21929907 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Pelvic Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Jamie Murphy, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ovuefe Efeotor

CONTACT

+447729459614; oe408@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: July 11, 2019
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)