Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Hyperthermia
Intervention: cisplatin; hyperthermia treatment; brachytherapy; external beam radiation therapy
Intervention description: Given IV; Patients undergo hyperthermia treatment over 60-90 minutes; Patients undergo brachytherapy for 2-3 days; Patients undergo external beam radiation therapy once daily on days 1-5
Intervention MeSH terms: Cisplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop
      tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy
      x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to
      several degrees above body temperature. It is not yet known whether chemotherapy and
      radiation therapy are more effective with or without hyperthermia therapy in treating
      cervical cancer.

      PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and
      radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy
      alone in the treatment of locally advanced cervical cancer.
    

Eligibility criteria:

        Inclusion criteria:

        Invasive cervical carcinoma (squamous, adeno or adenosquamous histologies, small cell
        histology excluded)

          -  age >18years

          -  International Federation of Gynecology and Obstetrics ((FIGO) stage IB2, IIA-IVA, FIGO
             stages IA, IB1 with positive pelvic lymph nodes or parametria either on imaging
             techniques or pathologically involved at the time of surgery.

        patients undergoing surgical removal of the cervix and uterus are not eligible, parametria
        either on imaging techniques or pathologically involved at the time • Performance status
        Eastern Cooperative Oncology Group(ECOG)/World Health Organisation (WHO) 0, 1 or
        >/=70%respectively White Blood count (WBC) ≥ 3,000, platelets ≥ 100,000, Absolute
        Neutrophil Count (ANC) > 1500

        • serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit of
        normal calculated creatinine clearance >60milliliters (mls)/liter ( Cockcroft) OR
        creatinine </= 2.0mgs% paraaortic adenopathy absent or 1.5 centimeter (cm) in greatest
        dimension on Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scan;

        No history of myocardial infarction in the last 6 months no symptomatic angina pectoris
        negative pregnancy test in patients under 50 Hemoglobin >12.0 Gd/dl or >7.5 mmo;/L with
        transfusion if needed written written informed consent

        Exclusion criteria:

        surgical resection of the primary tumor (i.e. Total abdominal hysterectomy (TAH)/ Bilateral
        salpingoophorectomy (BSO)

          -  patients with pacemakers or implanted defibrillators

          -  patients with significant metallic foreign bodies (i.e. hip replacements, bone
             metallic rods,orthopedic plates, etc.)

          -  prior radiotherapy or chemotherapy