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

Sponsor

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

Overall Status

Unknown status

CT.gov ID

NCT00008112

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin Procedure: hyperthermia treatment Radiation: brachytherapy Radiation: radiation therapy	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Academisch Medisch Centrum	Amsterdam	Netherlands	1105 AZ
2	University Hospital - Rotterdam Dijkzigt	Rotterdam	Netherlands	3000 CA
3	Rotterdam Cancer Institute	Rotterdam	Netherlands	3075 EA
4	Academisch Ziekenhuis Utrecht	Utrecht	Netherlands	3584 CX