Back to resultsModulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa (mEHT)
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Modulated electro-hyperthermia
External beam radiation
Cisplatin
Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Hyperthermia, cervix, HIV
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
-
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Charlotte Maxeke Johannesburg Academic HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study
Control
Arm Description
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)
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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).
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT03332069
First Posted
August 27, 2017
Last Updated
November 3, 2017
Sponsor
Jeffrey Kotzen
Collaborators
National Research Foundation of South Africa, NTP Radioisotopes SOC Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03332069
Brief Title
Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa
Acronym
mEHT
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2014 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Kotzen
Collaborators
National Research Foundation of South Africa, NTP Radioisotopes SOC Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Hyperthermia, cervix, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Clinicians conducting follow up evaluations, radiographers and nuclear medicine physicians reporting on the PET/CT investigations are unaware of the group that the participants have been assigned to.
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Modulated electro-hyperthermia
Other Intervention Name(s)
Oncothermia, Nanothermia
Intervention Description
Modulated electro-hyperthermia device used is the EHY 2000 by Oncotherm GmbH
Intervention Type
Radiation
Intervention Name(s)
External beam radiation
Other Intervention Name(s)
Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Other Intervention Name(s)
Radiation therapy
Intervention Description
High Dose Rate
Primary Outcome Measure Information:
Title
Change in Local Disease Control
Description
Assessed by PET/CT using the RESIST/PERSIST criteria: complete response, complete metabolic response, partial response, stable disease, progressive disease.
Time Frame
6 months post treatment
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Time Frame
24 months post treatment
Title
2 Year Survival
Description
Determine the overall survival at two years and the cause of death (i.e. cancer-related, HIV-related, treatment related or other).
Time Frame
24 months post treatment
Title
Incidence of Adverse Events Attributed to mEHT as assessed by CTCAE version 4.0
Description
To evaluate the adverse events that can be directly attributed to mEHT treatments.
Time Frame
6 months post treatment
Title
Incidence of Treatment Related Adverse Events Attributed to Cisplatin as assessed by CTCAE version 4.0
Description
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.
Time Frame
Up to 3 months post treatment completion
Title
Number of participants with Early Treatment Related Adverse Events as assessed by CTCAE version 4.0
Description
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.
Time Frame
Up to 6 months post treatment completion
Title
Number of participants with Late Treatment Related Adverse Events as assessed by CTCAE version 4.0
Description
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.
Time Frame
Up to 24 months post treatment completion
Title
Visual Analogue Scale On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Mobility On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Self-Care On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Usual Activities On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Pain/Discomfort On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Anxiety/Depression On the EuroQoL EQ-5D-5L form
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Global Health Status
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Physical Functioning
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Role Functioning
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Emotional Functioning
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Cognitive Functioning
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Social Functioning
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Fatigue
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Nausea and Vomiting
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Pain
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Dyspnoea
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Insomnia
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Appetite Loss
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Constipation
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Diarrhoea
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 30 for Financial Difficulties
Description
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
Time Frame
Up to 24 months post treatment completion
Title
Score on the EORTC-QLQ 24 for Symptom Experiences
Description
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
Time Frame
Up to 24 months post treatment completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
-
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie A Minnaar, PhD student
Phone
+27721234292
Email
cazzminn1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey A Kotzen, MBCHB
Phone
+27825747985
Email
jkotzen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie A Minnaar, Msc
Organizational Affiliation
Student - PhD Candidate
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey A Kotzen, MBBCH
Organizational Affiliation
Senior Radiation Oncologist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ans Baeyes, PhD
Organizational Affiliation
Head of Department of Radiobiology
Official's Role
Study Chair
Facility Information:
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2163
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Kotzen, MBBCH
Phone
+27825747385
First Name & Middle Initial & Last Name & Degree
Carrie A Minnaar, Masters
Phone
+27721234292
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17998673
Citation
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.
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PubMed Identifier
11820462
Citation
van 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. Erratum In: Int J Hyperthermia. 2003 Mar-Apr;19(2):213.
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PubMed Identifier
32180481
Citation
Minnaar 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.
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PubMed Identifier
31216321
Citation
Minnaar 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.
Results Reference
derived
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Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa
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