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

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

Sponsoren

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

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Unknown status
Anfangsdatum June 2000
Phase Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: cisplatin

Interventionsart: Procedure

Interventionsname: hyperthermia treatment

Interventionsart: Radiation

Interventionsname: brachytherapy

Interventionsart: Radiation

Interventionsname: radiation therapy

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Female

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Anneke M. Westermann, MD, PhD Study Chair Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ort
Einrichtung:
Academisch Medisch Centrum | Amsterdam, 1105 AZ, Netherlands
University Hospital - Rotterdam Dijkzigt | Rotterdam, 3000 CA, Netherlands
Rotterdam Cancer Institute | Rotterdam, 3075 EA, Netherlands
Academisch Ziekenhuis Utrecht | Utrecht, 3584 CX, Netherlands
Standort Länder

Netherlands

Überprüfungsdatum

October 2002

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Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov