Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

August 6, 2013 updated by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer

RATIONALE: Drugs used in chemotherapy use 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. Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV cervical cancer.

Study Overview

Status

Unknown

Conditions

Cervical Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer.
Determine the acute toxicity of this regimen in these patients.
Determine the complete response rate of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo external beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. On 1 day of each week, patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT. During week 6, patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy. Treatment continues in the absence of unacceptable toxicity.

Patients are followed at 6-8 weeks, every 3 months for 3 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 6-34 patients will be accrued for this study.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum
  - Rotterdam, Netherlands, 3075 EA
    - Rotterdam Cancer Institute
  - Rotterdam, Netherlands, 3000 CA
    - University Hospital - Rotterdam Dijkzigt
  - Utrecht, Netherlands, 3584 CX
    - Academisch Ziekenhuis Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix
- Adenocarcinoma
- Squamous cell carcinoma
- Mixed cell histology
- No small cell anaplastic histology
No para-aortic lymph node involvement
- No indication for para-aortic radiotherapy
No distant metastases
No CNS disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

WHO 0-2

Life expectancy:

More than 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL)
Epoetin alfa and/or transfusion allowed

Hepatic:

Not specified

Renal:

Glomerular filtration rate at least 60 mL/min

Cardiovascular:

No myocardial infarction within the past 6 months
No unstable angina
No congestive heart failure with expected inability to tolerate fluid load
No cerebrovascular accident within the past 6 months

Other:

No pacemaker and/or metal implants
No active uncontrolled infection
No compromised immune status
No psychosis
No other prior malignancy except nonmelanoma skin cancer
No mental or other physical inability that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy

Surgery:

No prior surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Study Chair: Anneke M. Westermann, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

June 4, 2003

First Posted (ESTIMATE)

June 5, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

October 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DUT-KWF-CKVO-2000-02
CDR0000068376 (REGISTRY: PDQ (Physician Data Query))
EU-20036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.