Cervical Cancer Clinical Trial
Official title:
High Intensity Focused Ultrasound as a Treatment for Rectal and Pelvic Cancers - Laboratory and Clinical Feasibility Studies
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.
The hypothesis of this study is that high intensity focused ultrasound (HIFU) can be safely
and effectively used to treat rectal and advanced pelvic cancers. This study is composed of
two feasibility trials to evaluate the safety and efficacy of use in HIFU in early rectal
cancer and late pelvic cancer.
The first trial will involve a cohort of 30 patients with early rectal cancer. They will have
full work up as per normal care including history, examination, bloods, endoscopy and imaging
(CT and MRI scan). Once eligibility has been confirmed, patients will be approached and
offered to be enrolled in the study. Once successfully recruited, they will be admitted
transrectal HIFU using the Sonatherm (Sonacare Medical, Charlotte, North Carolina, USA)
device under general anaesthetic with monitoring for toxicity. Baseline quality of life
questionnaires will be filled in by patients prior to HIFU to establish their symptoms prior
to treatment. Patients will be admitted for treatment and observed overnight. They will then
complete the same questionnaires at two and seven days post HIFU. Blood tests will be taken
one week after HIFU administration to monitor levels of tumour markers and inflammatory
markers. One week after their HIFU treatment, the patients will undergo their total
mesorectal excision (TME) to remove their cancer as per normal treatment protocol. The
specimen will be examined to evaluate the histological changes in the tumour and surrounding
tissues created by the HIFU. We will be able to quantify the effect of HIFU on the rectal
cancer and evaluate for possible thermal damage to surrounding tissues.
Potential patients will be identified during multidisciplinary team (MDT) meetings which
include surgeons, radiologists, oncologists and cancer nurse specialists. The team will
confirm eligibility and suitability prior to patient recruitment to ensure there is no
negative effect on overall patient care due to their involvement in the trial.
The Sonathermâ„¢ systems used ultrasound visualisation to monitor and regulate the HIFU
delivery. This allows tissue response to HIFU to be monitored via echogenic changes seen
during coagulative necrosis. The strong correlation between echogenic changes and tissue
destruction will allow us to alter the power settings if needed to achieve suitable ablation
of the target area. A video record of the ultrasound and ablation will be reviewed by the
team to evaluate the quality of the ablation performed.
The trial will run for approximately 1 month for each patient: from recruitment into the
study to the resection of the cancer. The HIFU dose will cover the entire tumour, the rectal
wall, and a 5 mm margin of tissue surrounding the tumour. It is anticipated that all tissue
exposed to HIFU, including the rectal wall, will be part of the coagulative necrosis.
Antibiotic prophylaxis will be given for five days to reduce the risk of abscess formation
and sepsis. Patients will be followed up on day 2 post HIFU and the day of their TME to
assess their response to treatment and any complications that develop. Post resection the
patients will be followed up as per the normal local guidelines following surgical excision
of rectal cancer. They will have their quality of life post resection assessed by completing
questionnaires 30 days post resection.
The second part of the study will involve a cohort of 30 patients with either locally
advanced pelvic cancer (rectal, endometrial or cervical) or locally recurrent disease. These
patients will be unsuitable for operative intervention or any further chemo-radiotherapy
treatment. They will have full work up as per normal care including history, examination,
bloods, endoscopy and imaging (CT and MRI scan). Once eligibility has been confirmed,
patients will be approached and offered to be enrolled in the study. Once successfully
recruited, they will be admitted intracavity HIFU using the Sonathermâ„¢ device under general
anaesthetic with monitoring for toxicity. Baseline quality of life questionnaires will be
filled in by patients prior to HIFU to establish their symptoms prior to treatment. Patients
will be admitted for treatment with HIFU and observed overnight to monitor for any toxicity
related to treatment with HIFU. Antibiotic prophylaxis will be given for five days to reduce
the risk of abscess formation and sepsis. Patients will be followed up closely to monitor for
toxicity and any changes in symptom control/quality of life. Patients will complete the same
pre-operative questionnaires at multiple time-points post HIFU treatment. Questionnaires will
be completed at seven, thirty, sixty and ninety days post HIFU, and three-monthly thereafter.
This will enable us to accurately chart the change in quality of life and symptom control
created by the HIFU treatment. Post-treatment imaging will be performed at between 3-4 weeks,
as within this time frame the ablative effect (a necrotic area) as seen in prostate cancer
treated by HIFU. This will allow comparison with pre-operative imaging to evaluate the effect
of HIFU. A video record of the ultrasound and ablation will be reviewed by the team to
evaluate the quality of the ablation performed.
Patients will be reviewed at regular intervals after treatment with HIFU to monitor the
effect of HIFU on quality of life. Regular blood tests will be taken to monitor tumour
markers and markers of systemic inflammation.
Potential patients will be identified during MDT meetings which include surgeons,
radiologists, gynaecologists, oncologists and cancer nurse specialists. The team will confirm
eligibility and suitability prior to patient recruitment. If felt appropriate by the MDT,
patients may be offered a second application of HIFU as necessary.
The trial will run in two stages: the end of the first phase (for regulatory requirements) is
defined as 30 days from the date that the last patient has completed trial therapy. The
non-interventional follow-up stage will then commence in which patients are followed up for a
minimum of 6 months or death.
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