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An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer


OBJECTIVES:

- Compare local control, failure-free survival, and overall survival of patients with
locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy with
vs without hyperthermia .

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (< 60 years vs ≥ 60
years). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV and concurrently undergo hyperthermia over 60-90
minutes on day 1. Patients also undergo external beam radiotherapy once daily on days
1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or
unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients
undergo brachytherapy to the cervix for 2-3 days.

- Arm II: Patients receive cisplatin and undergo radiotherapy (including brachytherapy)
as in arm I.

Patients are followed at 4-6 weeks, every 3 months for 2 years, every 6 months for 5 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 5 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

r Primary tumor response rate at 4-6 weeks post treatment

Outcome Time Frame:

3 months from start of therapy

Safety Issue:

No

Principal Investigator

Ellen L. Jones, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

Pro00005267

NCT ID:

NCT00085631

Start Date:

February 2004

Completion Date:

October 2009

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms
  • Fever

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611