Cervical Cancer Clinical Trial
Official title:
High Intensity Focused Ultrasound as a Treatment for Rectal and Pelvic Cancers - Laboratory and Clinical Feasibility Studies
NCT number | NCT03595722 |
Other study ID # | 18SM4430 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 11, 2019 |
Est. completion date | August 28, 2022 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 28, 2022 |
Est. primary completion date | August 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: Early rectal cancer arm: 1. Biopsy proven rectal cancer <15cm from anal verge 2. Targeted region = 3cm in depth dimension, deepest region of tumour = 3.5cm from organ/tissue surface accessible by the probe 3. Tumour accessible by the HIFU probe via suitable acoustic window 4. Early stage disease not requiring neo-adjuvant chemo radiotherapy prior to TME - T1/T2 but confirmed to require adjuvant chemotherapy 5. Ability to undergo an intraluminal ultrasound examination 6. World Health Organisation (WHO) Performance Status 0-3 7. Age =18 and fit for general anaesthetic and HIFU 8. For women of child bearing potential, not pregnant 9. No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment 10. Written informed consent for treatment Late pelvic cancer arm: 1. Biopsy proven rectal, vaginal, endometrial or cervical cancer (tumour <15cm from anal/vaginal verge) 2. Solid tumour/mass = 3cm in depth dimension, deepest region of tumour = 3.5cm from organ/tissue surface accessible by the probe 3. Lymph node(s) accessible by HIFU for which the primary clinical team advise intervention 4. Tumour accessible by the HIFU probe via suitable acoustic window 5. Partially fixed/unresectable disease and locally advanced disease (T3/T4) 6. Ability to undergo an intraluminal ultrasound examination 7. WHO Performance Status 0-3 8. Age =18 and fit for general anaesthetic and HIFU 9. For women of child bearing potential, not pregnant 10. No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment 11. Written informed consent for treatment Exclusion Criteria: Early rectal cancer arm: 1. WHO performance status of 4 2. Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent 3. Pelvic sepsis 4. Currently enrolled in any neo-adjuvant treatment trial that may induce tumour regression 5. Locally advanced disease - T3/T4 or patients who are not thought to require adjuvant therapy 6. Tumours above peritoneal reflection or below dentate line 7. Subjects with tumours lying < 1cm from sensitive structures/organs Late pelvic cancer arm: 1. WHO performance status of 4 2. Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent 3. Pelvic sepsis 4. Currently enrolled in any other palliative treatment trial that may confound results 5. Subjects with tumours lying < 1cm from sensitive structures/organs |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | SonaCare Medical |
United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Thüroff 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complications | Complications and toxicity of HIFU treatment | 0-30 days | |
Secondary | Symptom control | Quality of life questionnaire responses | 7-90 days | |
Secondary | Histological tissue changes | Histological changes in tumour and surrounding tissue | 7-10 days | |
Secondary | Tumour marker changes | Changes in circulating tumour markers | 7-90 days | |
Secondary | Inflammatory marker changes | changes in circulating inflammatory markers | 7-90 days | |
Secondary | Radiological changes | MRI changes in tumour | 30 days |
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