Clinical trial NCT00085631: Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer
Official title: An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cervical Cancer
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Northwestern University
First posted: 2004-06-11
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with 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.

LIMITATIONS:

There are integrity issues with the currently available data, involving international institutions, in that several pieces of information relating to patient accrual and outcomes cannot be verified. Therefore, it would be inappropriate to report outcome measures for this study. Baseline measures of age and gender are reported for the entire study cohort. Participant flow is reported by treatment arm assignment, which was available for a majority of patients in the currently available data. Adverse events are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

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

Primary outcomes:
measure: Primary Tumor Response Rate at 4-6 Weeks Post Treatment
timeFrame: 3 months from start of therapy
measure: Five-year Failure-free Survival
timeFrame: 5 Years
measure: Five-Year Local Recurrence-Free Survival
timeFrame: 5 years
measure: Five-Year Overall Survival
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Ellen L. Jones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Cancer Institute
name: Leonard R. Prosnitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Cancer Institute
name: Mark Dewhirst, DVM PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Cancer Institute
name: Zeljko Vujaskovic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: