Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer

Stopped early · Phase 3

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT00085631

Run by

Mark Dewhirst

People needed

101

Starts

2003-03-01

Expected to finish

2009-06-01

Last updated by the study team

2013-09-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke Cancer Institute — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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