Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Procedure: hyperthermia treatment Radiation: brachytherapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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: | June 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Study Chair: | Anneke M. Westermann, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008112 History of Changes |
| Other Study ID Numbers: | CDR0000068376, DUT-KWF-CKVO-2000-02, EU-20036 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III cervical cancer stage IIB cervical cancer stage IVA cervical cancer |
cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Fever Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Body Temperature Changes Signs and Symptoms Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013