Cervical CancerPhase 3mEHTNCT03332069
Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa
A Phase 3 study testing Modulated electro-hyperthermia, External beam radiation and Cisplatin in people with Cervical Cancer, run by Jeffrey Kotzen at 1 site in South Africa.
Trial summary
This is a phase III randomised clinical trial. The aim is to investigate the clinical effects of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols (chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally advanced cervical cancer patients (LACC). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Modulated electro-hyperthermia, External beam radiation and Cisplatin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteSouth Africa
- Study dates
- 9 Jan 2014to 31 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants (who have been adequately clinically staged by standard clinical guidelines) with biopsy proven primary, untreated, histologically confirmed invasive squamous and aden-squamous cell carcinoma of the uterine cervix, FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) stages advanced IIB (invasion of the distal half of the parametrium), IIIA and IIIB.
- HIV positive participants will be accepted.
- The following laboratory tests will be done prior to enrolment in the study and the values must be in the following ranges:
- Haemoglobin >10 g/dL;
- Platelet count >150/mm3;
- Absolute neutrophil count (ANC) >3000/mm3
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- Creatinine clearance>60 mL/min
- Liver function tests
- Females between the ages of 18 and 70 years.
- Ability to understand and the willingness to sign a written informed consent document.
- Eastern Cooperative Oncology Group (ECOG) score of not more than 2.
- Participants of childbearing potential must have a negative urine or serum pregnancy test prior to enrolment and use an effective form of contraception (e.g. barrier contraception, highly effective hormonal contraception).
- At the investigators' discretion, participants must be suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiation. Subjects who undergo emergency RT in the form of brachytherapy for haemostasis, prior to enrolment will be allowed to be screened and enrolled provided they meet all other eligibility criteria.
- Life expectancy of greater than 12 months.
- Participants must have a body mass index (BMI) that is within normal ranges.
- -
Who cannot join
- Participants who have undergone hysterectomy.
- Exclude para-aortic lymph involvement on planning CT (without contrast)
- Patients with life-threatening AIDS defining illnesses (other than cervical carcinoma) will be excluded, as will patients with a CD4 count < 200/µL and not on ARVs.
- Patients with acute active (such as tuberculosis or malaria), serious, uncontrolled infections will be excluded.
- Participants will be excluded if there is evidence of resistance to antiretroviral therapy (i.e. HIV viral load > 400 copies/mL despite combination antiretroviral therapy for at least 4 months).
- Prior invasive malignancy other than cervical cancer, diagnosed within the past 24 months, excluding in situ anal dysplasia or carcinoma in situ, non-melanoma skin carcinoma, or Kaposi's sarcoma that has not required systemic chemotherapy within the past 24 months.
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- Pregnant or breast-feeding women.
- A medical or psychiatric illness that prevents the participant from being able to sign an informed consent or would affect the participant's ability to comply with the protocol stipulations.
- Participants with circumstances that will not permit completion of the study or required follow-ups. For instance if travel to and from treatment site is an issue.
- Participants with carcinoma of the cervical stump.
- Participants with a history of cardiovascular disease manifested as
- History of myocardial infarction
- Unstable angina
- Currently taking medication for treatment of angina
- History of coronary artery bypass surgery
- Participants with contraindications to modulated electro-hyperthermia treatment:
- Pace makers and other implanted devices which rely on current and charges.
- Large metal implants, such as hip replacements.
- Inability to feel temperature in the region.
- Inability to express or vocalise discomfort or heat at the treatment site.
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2163
Jeffrey A Kotzen, MBBCH, +27825747385
Carrie A Minnaar, Masters, +27721234292
About this study
Official title: A Phase III Randomised Trial Investigating the Benefits of the Addition of Modulated Electro-hyperthermia to Chemo-radiation for Cervical Cancer in HIV Positive and Negative Women in South Africa
This is a phase III randomised clinical trial. The aim is to investigate the clinical effects of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols (chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally advanced cervical cancer patients (LACC). SAMPLE: The investigators aim to enrol 236 HIV negative and HIV positive women with LACC, FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) Stages IIB (distil) to stage III. Participants will be randomly assigned to a control group (N=118) and a study group (N=118). METHODOLOGY: Randomisation is based on age, stage and HIV. Participants from both groups will receive the standard treatment for cervical cancer at the hospital at the Charlotte Maxeke Johannesburg Academic Hospital in South Africa: Up to three doses of 80mg/m2 cisplatin, administered three weeks apart; 50Gy external beam radiation (EBR) in fractions of 2Gy; Three doses of 8Gy High Dose Rate (HDR) brachytherapy. The study group will have two 55 minute mEHT treatments per week, at 130W, directly before the EBR using the EHY 2000 Device. OUTCOMES: 1) Determine the local disease control after treatment at 6 months using a Positron Emission Tomography (PET) and computerised tomography (CT) scans. 2) Determine the progression-free survival (PFS) at 6, 12, 18 and 24 months after the last treatment date. PFS will be assessed in all registered participants, regardless of completion (Intent to Treat-ITT) as well as only in the subset of participants who complete the prescribed CRT. 3) Overall survival at two years will be assessed. 4) To evaluate the adverse events associated with mEHT. 5) The effect of mEHT on chemotherapy and radiotherapy tolerability and toxicity will be evaluated. 6) The quality of life of enrolled participants will be assessed before, at 6 weeks, and at 3, 6, 9, 12, 18 and 24 months after completion of therapy using the EORTC (European Organisation for Research and Treatment of Cancer) and EuroQoL forms. 7) To evaluate the economic viability of the addition of mEHT to standard treatment protocols for LACC. 8) The effect, if any, of mEHT treatments on the HIV disease status of HIV positive patients will be assessed by the presence of Autoimmune Deficiency Syndrome (AIDS) defining illnesses before and after treatment. 9) The cancer recurrence patterns will be described and compared in all the participants.
- Conditions
- Cervical Cancer
- Being tested
- Modulated electro-hyperthermia, External beam radiation, Cisplatin, Brachytherapy
- Keywords
- Hyperthermia, cervix, HIV
- Medical subject headings
- Uterine Cervical Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulated electro-hyperthermiaDevice
Also called Oncothermia, Nanothermia
Modulated electro-hyperthermia device used is the EHY 2000 by Oncotherm GmbH
External beam radiationRadiation
Also called Radiotherapy
CisplatinDrug
Also called Chemotherapy
BrachytherapyRadiation
Also called Radiation therapy
High Dose Rate
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | 50 Gy external beam radiation administered in fractions of 2 Gy 3 Doses of 8 Gy High Dose Rate brachytherapy up to 3 doses of 80mg/m2 of Cisplatin 10 modulated electro-hyperthermia treatments (55 minutes at a maximum of 150W) Receives: Device: Modulated electro-hyperthermia; Radiation: External beam radiation; Drug: Cisplatin; Radiation: Brachytherapy |
| Control | Active comparator | 50 Gy external beam radiation administered in fractions of 2 Gy 3 Doses of 8 Gy High Dose Rate brachytherapy up to 3 doses of 80mg/m2 of Cisplatin Receives: Radiation: External beam radiation; Drug: Cisplatin; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Local Disease Control
Assessed by PET/CT using the RESIST/PERSIST criteria: complete response, complete metabolic response, partial response, stable disease, progressive disease.
Measured: 6 months post treatment
Secondary outcomes (28)
Progression Free Survival
To determine the progression-free survival (PFS) at 6, 12, 18 and 24 months after the last treatment date.
- Determine PFS in all registered participants, regardless of completion (Intent To Treat-ITT)
- Determine PFS in the subset of participants who complete the prescribed chemo-radiotherapy
Measured: 24 months post treatment
2 Year Survival
Determine the overall survival at two years and the cause of death (i.e. cancer-related, HIV-related, treatment related or other).
Measured: 24 months post treatment
Incidence of Adverse Events Attributed to mEHT as assessed by CTCAE version 4.0
To evaluate the adverse events that can be directly attributed to mEHT treatments.
Measured: 6 months post treatment
Incidence of Treatment Related Adverse Events Attributed to Cisplatin as assessed by CTCAE version 4.0
The incidence of treatment-emergent adverse events which can be attributed to Cisplatin in each arm will be compared in order to identify any potential effect of mEHT on the frequency and severity of adverse events attributed to Cisplatin.
Measured: Up to 3 months post treatment completion
Number of participants with Early Treatment Related Adverse Events as assessed by CTCAE version 4.0
The incidence of early toxicity symptoms (graded using the CTCAE version 4 criteria) associated with radiotherapy in each arm of the study will be compared to identify any potential effect of the mEHT on the incidence and severity of early toxicity.
Measured: Up to 6 months post treatment completion
Number of participants with Late Treatment Related Adverse Events as assessed by CTCAE version 4.0
The incidence of late toxicity symptoms (graded using the CTCAE version 4 criteria) associated with radiotherapy in each arm of the study will be compared to identify any potential effect of the mEHT on the incidence of late toxicity in the sample group.
Measured: Up to 24 months post treatment completion
Visual Analogue Scale On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Visual Analogue Scale on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Mobility On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of Mobility on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Self-Care On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of Self-Care on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Usual Activities On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of Usual Activities on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Pain/Discomfort On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of Pain/Discomfort on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Anxiety/Depression On the EuroQoL EQ-5D-5L form
To evaluate the changes from baseline value at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of Anxiety/Depression on the EuroQoL EQ-5D-5L form
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Global Health Status
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Global Health Status
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Physical Functioning
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Physical Functioning
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Role Functioning
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Role Functioning
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Emotional Functioning
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Emotional Functioning
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Cognitive Functioning
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Cognitive Functioning
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Social Functioning
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Social Functioning
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Fatigue
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Fatigue
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Nausea and Vomiting
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Nausea and Vomiting
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Pain
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Pain
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Dyspnoea
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Dyspnoea
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Insomnia
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Insomnia
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Appetite Loss
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Appetite Loss
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Constipation
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Constipation
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Diarrhoea
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Diarrhoea
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Financial Difficulties
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Financial Difficulties
Measured: Up to 24 months post treatment completion
Score on the EORTC-QLQ 24 for Symptom Experiences
To evaluate the changes from baseline scores at set time points (6 weeks, 3 months, 6 months, 9 months, 12 months,18 months, 24 months) of the Score on the EORTC-QLQ 30 for Symptom Experiences
Measured: Up to 24 months post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Jan 2014
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Kotzen
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of South Africa, NTP Radioisotopes SOC Ltd
- Responsible party
- Sponsor-investigator, Jeffrey Kotzen, University of Witwatersrand, South Africa
- Investigators
- Carrie A Minnaar, Msc, Study chair, Student - PhD CandidateJeffrey A Kotzen, MBBCH, Principal investigator, Senior Radiation OncologistAns Baeyes, PhD, Study chair, Head of Department of Radiobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332069
- Sponsor's protocol ID
- LACC-OT
- Acronym
- mEHT
- Status last verified
- Nov 2017
- First submitted
- 27 Aug 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fiorentini G, Szasz A. Hyperthermia today: electric energy, a new opportunity in cancer treatment. J Cancer Res Ther. 2006 Apr-Jun;2(2):41-6. doi: 10.4103/0973-1482.25848.
PubMed 17998673van der Zee J, Gonzalez GD. The Dutch Deep Hyperthermia Trial: results in cervical cancer. Int J Hyperthermia. 2002 Jan-Feb;18(1):1-12. doi: 10.1080/02656730110091919.
PubMed 11820462Minnaar CA, Kotzen JA, Naidoo T, Tunmer M, Sharma V, Vangu MD, Baeyens A. Analysis of the effects of mEHT on the treatment-related toxicity and quality of life of HIV-positive cervical cancer patients. Int J Hyperthermia. 2020;37(1):263-272. doi: 10.1080/02656736.2020.1737253.
PubMed 32180481Minnaar CA, Kotzen JA, Ayeni OA, Naidoo T, Tunmer M, Sharma V, Vangu MD, Baeyens A. The effect of modulated electro-hyperthermia on local disease control in HIV-positive and -negative cervical cancer women in South Africa: Early results from a phase III randomised controlled trial. PLoS One. 2019 Jun 19;14(6):e0217894. doi: 10.1371/journal.pone.0217894. eCollection 2019.
PubMed 31216321
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised Trial Investigating the Benefits of the Addition of Modulated Electro-hyperthermia to Chemo-radiation for Cervical Cancer in HIV Positive and Negative Women in South Africa
- ClinicalTrials.gov ID
- NCT03332069
- Acronym / sponsor ID
- mEHT / LACC-OT
- Conditions
- Cervical Cancer
- Keywords
- Hyperthermia, cervix, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Jeffrey KotzenUniversity, hospital or other
- Collaborators
- National Research Foundation of South Africa, NTP Radioisotopes SOC Ltd
- Study start
- 9 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III randomised clinical trial. The aim is to investigate the clinical effects of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols (chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally advanced cervical cancer patients (LACC). SAMPLE: The investigators aim to enrol 236 HIV negative and HIV positive women with LACC, FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) Stages IIB (distil) to stage III. Participants will be randomly assigned to a control group (N=118) and a study group (N=118). METHODOLOGY: Randomisation is based on age, stage and HIV. Participants from both groups will receive the standard treatment for cervical cancer at the hospital at the Charlotte Maxeke Johannesburg Academic Hospital in South Africa: Up to three doses of 80mg/m2 cisplatin, administered three weeks apart; 50Gy external beam radiation (EBR) in fractions of 2Gy; Three doses of 8Gy High Dose Rate (HDR) brachytherapy. The study group will have two 55 minute mEHT treatments per week, at 130W, directly before the EBR using the EHY 2000 Device. OUTCOMES: 1) Determine the local disease control after treatment at 6 months using a Positron Emission Tomography (PET) and computerised tomography (CT) scans. 2) Determine the progression-free survival (PFS) at 6, 12, 18 and 24 months after the last treatment date. PFS will be assessed in all registered participants, regardless of completion (Intent to Treat-ITT) as well as only in the subset of participants who complete the prescribed CRT. 3) Overall survival at two years will be assessed. 4) To evaluate the adverse events associated with mEHT. 5) The effect of mEHT on chemotherapy and radiotherapy tolerability and toxicity will be evaluated. 6) The quality of life of enrolled participants will be assessed before, at 6 weeks, and at 3, 6, 9, 12, 18 and 24 months after completion of therapy using the EORTC (European Organisation for Research and Treatment of Cancer) and EuroQoL forms. 7) To evaluate the economic viability of the addition of mEHT to standard treatment protocols for LACC. 8) The effect, if any, of mEHT treatments on the HIV disease status of HIV positive patients will be assessed by the presence of Autoimmune Deficiency Syndrome (AIDS) defining illnesses before and after treatment. 9) The cancer recurrence patterns will be described and compared in all the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: Modulated electro-hyperthermia, Radiation: External beam radiation, Drug: Cisplatin, Radiation: Brachytherapy50 Gy external beam radiation administered in fractions of 2 Gy 3 Doses of 8 Gy High Dose Rate brachytherapy up to 3 doses of 80mg/m2 of Cisplatin 10 modulated electro-hyperthermia treatments (55 minutes at a maximum of 150W) |
| Control | Active comparator | Radiation: External beam radiation, Drug: Cisplatin, Radiation: Brachytherapy50 Gy external beam radiation administered in fractions of 2 Gy 3 Doses of 8 Gy High Dose Rate brachytherapy up to 3 doses of 80mg/m2 of Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants (who have been adequately clinically staged by standard clinical guidelines) with biopsy proven primary, untreated, histologically confirmed invasive squamous and aden-squamous cell carcinoma of the uterine cervix, FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) stages advanced IIB (invasion of the distal half of the parametrium), IIIA and IIIB.
- HIV positive participants will be accepted.
- The following laboratory tests will be done prior to enrolment in the study and the values must be in the following ranges:
- Females between the ages of 18 and 70 years.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (20 listed)
- Participants who have undergone hysterectomy.
- Exclude para-aortic lymph involvement on planning CT (without contrast)
- Patients with life-threatening AIDS defining illnesses (other than cervical carcinoma) will be excluded, as will patients with a CD4 count < 200/µL and not on ARVs.
- Patients with acute active (such as tuberculosis or malaria), serious, uncontrolled infections will be excluded.
- Participants will be excluded if there is evidence of resistance to antiretroviral therapy (i.e. HIV viral load > 400 copies/mL despite combination antiretroviral therapy for at least 4 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modulated electro-hyperthermiaAlso: Oncothermia, NanothermiaModulated electro-hyperthermia device used is the EHY 2000 by Oncotherm GmbH | Device | Study |
| External beam radiationAlso: Radiotherapy | Radiation | Control, Study |
| CisplatinAlso: Chemotherapy | Drug | Control, Study |
| BrachytherapyAlso: Radiation therapyHigh Dose Rate | Radiation | Control, Study |
Primary outcome
Change in Local Disease Control
Time frame: 6 months post treatment
Assessed by PET/CT using the RESIST/PERSIST criteria: complete response, complete metabolic response, partial response, stable disease, progressive disease.
28 secondary outcomes
Progression Free Survival
Time frame: 24 months post treatment
2 Year Survival
Time frame: 24 months post treatment
Incidence of Adverse Events Attributed to mEHT as assessed by CTCAE version 4.0
Time frame: 6 months post treatment
Incidence of Treatment Related Adverse Events Attributed to Cisplatin as assessed by CTCAE version 4.0
Time frame: Up to 3 months post treatment completion
Number of participants with Early Treatment Related Adverse Events as assessed by CTCAE version 4.0
Time frame: Up to 6 months post treatment completion
Number of participants with Late Treatment Related Adverse Events as assessed by CTCAE version 4.0
Time frame: Up to 24 months post treatment completion
Visual Analogue Scale On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Mobility On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Self-Care On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Usual Activities On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Pain/Discomfort On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Anxiety/Depression On the EuroQoL EQ-5D-5L form
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Global Health Status
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Physical Functioning
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Role Functioning
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Emotional Functioning
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Cognitive Functioning
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Social Functioning
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Fatigue
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Nausea and Vomiting
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Pain
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Dyspnoea
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Insomnia
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Appetite Loss
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Constipation
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Diarrhoea
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 30 for Financial Difficulties
Time frame: Up to 24 months post treatment completion
Score on the EORTC-QLQ 24 for Symptom Experiences
Time frame: Up to 24 months post treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 17998673Fiorentini G, Szasz A. Hyperthermia today: electric energy, a new opportunity in cancer treatment. J Cancer Res Ther. 2006 Apr-Jun;2(2):41-6. doi: 10.4103/0973-1482.25848.
- Background: PubMed 11820462van der Zee J, Gonzalez GD. The Dutch Deep Hyperthermia Trial: results in cervical cancer. Int J Hyperthermia. 2002 Jan-Feb;18(1):1-12. doi: 10.1080/02656730110091919.
- Derived from this study: PubMed 32180481Minnaar CA, Kotzen JA, Naidoo T, Tunmer M, Sharma V, Vangu MD, Baeyens A. Analysis of the effects of mEHT on the treatment-related toxicity and quality of life of HIV-positive cervical cancer patients. Int J Hyperthermia. 2020;37(1):263-272. doi: 10.1080/02656736.2020.1737253.
- Derived from this study: PubMed 31216321Minnaar CA, Kotzen JA, Ayeni OA, Naidoo T, Tunmer M, Sharma V, Vangu MD, Baeyens A. The effect of modulated electro-hyperthermia on local disease control in HIV-positive and -negative cervical cancer women in South Africa: Early results from a phase III randomised controlled trial. PLoS One. 2019 Jun 19;14(6):e0217894. doi: 10.1371/journal.pone.0217894. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie A Minnaar, Msc study chair
Student - PhD Candidate
Jeffrey A Kotzen, MBBCH principal investigator
Senior Radiation Oncologist
Ans Baeyes, PhD study chair
Head of Department of Radiobiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modulated electro-hyperthermia, External beam radiation and Cisplatin in people with Cervical Cancer, run by Jeffrey Kotzen at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carrie A Minnaar, PhD student (+27721234292, cazzminn1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Local Disease Control (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332069, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.