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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Anneke M. Westermann, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CDR0000068376

NCT ID:

NCT00008112

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IIB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms
  • Fever

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