NCT00008112

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

June 5, 2003

Completed
Last Updated

August 7, 2013

Status Verified

October 1, 2002

First QC Date

January 6, 2001

Last Update Submit

August 6, 2013

Conditions

Cervical Cancer

Keywords

stage III cervical cancerstage IIB cervical cancerstage IVA cervical cancercervical squamous cell carcinomacervical adenocarcinomacervical adenosquamous cell carcinoma

Interventions

cisplatinDRUG
hyperthermia treatmentPROCEDURE
brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinDiathermyBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHyperthermia, InducedTherapeutics

Study Officials

  • Anneke M. Westermann, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

June 5, 2003

Study Start

June 1, 2000

Last Updated

August 7, 2013

Record last verified: 2002-10

Locations

NL(4)