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

Sponsor:	Duke University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085631

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: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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 National Cancer Institute (NCI):

Primary Outcome Measures:

Response at 6-8 weeks post treatment [ Designated as safety issue: No ]
Disease-free survival assessed every 3 months for 2 years and then every 6 months for 5 years [ Designated as safety issue: No ]
Overall survival assessed every 3 months for 2 years and then every 6 months for 5 years [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	February 2004
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

Experimental: 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.

Drug: cisplatin

Given IV

Procedure: hyperthermia treatment

Patients undergo hyperthermia treatment over 60-90 minutes

Radiation: brachytherapy

Patients undergo brachytherapy for 2-3 days

Radiation: radiation therapy

Patients undergo radiation therapy once daily on days 1-5

Active Comparator: Arm II

Patients receive cisplatin and undergo radiotherapy (including brachytherapy) as in arm I.

Drug: cisplatin

Given IV

Radiation: brachytherapy

Patients undergo brachytherapy for 2-3 days

Radiation: radiation therapy

Patients undergo 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

DISEASE CHARACTERISTICS:

Histologically confirmed carcinoma of the cervix
- Invasive disease
- Squamous cell, adenocarcinoma or adenosquamous cell histologies eligible
  - No small cell histology
- Meets 1 of the following stage criteria:
  - Stage IIB-IVA
  - Stage IA, IB, or IIA with positive pelvic lymph nodes or parametria by imaging OR pathologically involved at time of surgery
Not undergoing complete resection of the primary tumor (i.e., total abdominal hysterectomy/bilateral salpingo-oophorectomy)
- Resection of pelvic lymph nodes allowed
No para-aortic adenopathy OR para-aortic adenopathy ≤ 1.5 cm in largest dimension by CT scan or MRI
- Patients with carcinoma in the para-aortic nodes by biopsy are ineligible

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
WHO 70-100%

Life expectancy

Not specified

Hematopoietic

WBC ≥ 3,000/mm^3
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count > 1,500/mm^3
Hemoglobin > 12.0 g/dL (transfusion allowed)

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Transaminase ≤ 3 times ULN

Renal

Creatinine clearance > 60 mL/min

Cardiovascular

No myocardial infarction within the past 6 months
No symptomatic angina pectoris

Other

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Other

No pacemakers or implanted defibrillators
No significant metallic foreign bodies (e.g., hip replacements, bone metallic rods, or orthopedic plates)

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

Duke University

National Cancer Institute (NCI)

Investigators

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

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:	Zeljko Vujaskovic, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00085631 History of Changes
Other Study ID Numbers:	CDR0000370860, DUMC-4516-04-2R1ER, DUMC-G030263, DUMC-4516031R0
Study First Received:	June 10, 2004
Last Updated:	July 21, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 February 09, 2012