Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer - Full Text View

Purpose

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 is studying how well giving cisplatin and radiation therapy together with hyperthermia therapy works compared to cisplatin and radiation therapy alone in treating patients with locally advanced cervical cancer.

Condition	Intervention	Phase
Cervical Cancer	Drug: cisplatin Procedure: hyperthermia treatment Radiation: brachytherapy Radiation: external beam radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Fever

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

r Primary tumor response rate at 4-6 weeks post treatment [ Time Frame: 3 months from start of therapy ] [ Designated as safety issue: No ]
Disease-free survival assessed every 3-6 months [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall survival assessed every 3 months for 2 years and then every 6 months for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	February 2004
Study Completion Date:	October 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive cisplatin IV and concurrently undergo hyperthermia treatment over 60-90 minutes on day 1. Patients also undergo external beam radiation therapy 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.	Drug: cisplatin Given IV Other Name: Platinol-AQ Procedure: hyperthermia treatment Patients undergo hyperthermia treatment over 60-90 minutes Radiation: brachytherapy Patients undergo brachytherapy for 2-3 days Radiation: external beam radiation therapy Patients undergo external beam radiation therapy once daily on days 1-5
Active Comparator: Arm II Patients receive cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.	Drug: cisplatin Given IV Other Name: Platinol-AQ Radiation: brachytherapy Patients undergo brachytherapy for 2-3 days Radiation: external beam radiation therapy Patients undergo external beam radiation therapy once daily on days 1-5

Arms

Assigned Interventions

Experimental: Arm I

Patients receive cisplatin IV and concurrently undergo hyperthermia treatment over 60-90 minutes on day 1. Patients also undergo external beam radiation therapy 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.

Drug: cisplatin

Given IV

Other Name: Platinol-AQ

Procedure: hyperthermia treatment

Patients undergo hyperthermia treatment over 60-90 minutes

Radiation: brachytherapy

Patients undergo brachytherapy for 2-3 days

Radiation: external beam radiation therapy

Patients undergo external beam radiation therapy once daily on days 1-5

Active Comparator: Arm II

Patients receive cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.

Drug: cisplatin

Given IV

Other Name: Platinol-AQ

Radiation: brachytherapy

Patients undergo brachytherapy for 2-3 days

Radiation: external beam radiation therapy

Patients undergo external beam radiation therapy once daily on days 1-5

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085631

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Germany
Charite University Hospital - Campus Virchow Klinikum
Berlin, Germany, D-13353
Strahlenklinik - Universitaetsklinikum Erlangen
Erlangen, Germany, D-91054
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Norway
Haukeland Hospital - University of Bergen
Bergen, Norway, N-5021

Sponsors and Collaborators

Mark Dewhirst

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Ellen L. Jones, MD, PhD	Duke Cancer Institute
Principal Investigator:	Leonard R. Prosnitz, MD	Duke Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mark Dewhirst, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00085631 History of Changes
Other Study ID Numbers:	Pro00005267, DUMC-4516, CDR0000370860
Study First Received:	June 10, 2004
Last Updated:	January 10, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Duke University:

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

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Fever
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases

Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013