Status:
UNKNOWN
Modulated Electro-Hyperthermia Plus Chemo-radiation for Locally Advanced Cervical Cancer Patients in South Africa
Lead Sponsor:
Jeffrey Kotzen
Collaborating Sponsors:
National Research Foundation of South Africa
NTP Radioisotopes SOC Ltd
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 (chemoradiotherap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT03332069
Start Date
January 9 2014
End Date
July 31 2020
Last Update
November 7 2017
Active Locations (1)
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1
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2163