Clinical trial NCT03332069 (phase 3, status: unknown status)
Conditions: cervical cancer
ICD codes: M50.20, M50.21, M50.30, M50.31, M50.80, M50.81, M50.90
Drugs: cisplatin
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. HIV positive participants will be accepted.

          3. 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

          4. Females between the ages of 18 and 70 years.

          5. Ability to understand and the willingness to sign a written informed consent document.

          6. Eastern Cooperative Oncology Group (ECOG) score of not more than 2.

          7. 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).

          8. 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.

          9. Life expectancy of greater than 12 months.

         10. Participants must have a body mass index (BMI) that is within normal ranges.

             -

        Exclusion Criteria:

          1. Participants who have undergone hysterectomy.

          2. Exclude para-aortic lymph involvement on planning CT (without contrast)

          3. 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.

          4. Patients with acute active (such as tuberculosis or malaria), serious, uncontrolled
             infections will be excluded.

          5. 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).

          6. 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.

          7. Pregnant or breast-feeding women.

          8. 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.

          9. 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.

         10. Participants with carcinoma of the cervical stump.

         11. Participants with a history of cardiovascular disease manifested as

               1. History of myocardial infarction

               2. Unstable angina

               3. Currently taking medication for treatment of angina

               4. History of coronary artery bypass surgery

         12. Participants with contraindications to modulated electro-hyperthermia treatment:

               1. Pace makers and other implanted devices which rely on current and charges.

               2. Large metal implants, such as hip replacements.

               3. Inability to feel temperature in the region.

               4. Inability to express or vocalise discomfort or heat at the treatment site.