Overview

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

Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mark Dewhirst
Collaborators:
National Cancer Institute (NCI)
Northwestern University
Treatments:
Cisplatin
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 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