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Sponsored by: |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008112 |
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 |
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Cervical Cancer |
Drug: cisplatin Procedure: hyperthermia treatment Radiation: brachytherapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | 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:
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.
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
No para-aortic lymph node involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Netherlands | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Academisch Ziekenhuis Utrecht | |
Utrecht, Netherlands, 3584 CX | |
Rotterdam Cancer Institute | |
Rotterdam, Netherlands, 3075 EA | |
University Hospital - Rotterdam Dijkzigt | |
Rotterdam, Netherlands, 3000 CA |
Study Chair: | Anneke M. Westermann, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Study ID Numbers: | CDR0000068376, DUT-KWF-CKVO-2000-02, EU-20036 |
Study First Received: | January 6, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00008112 History of Changes |
Health Authority: | United States: Federal Government |
stage III cervical cancer stage IIB cervical cancer stage IVA cervical cancer |
cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma |
Fever Radiation-Sensitizing Agents Cisplatin Epidermoid Carcinoma Squamous Cell Carcinoma |
Adenocarcinoma Carcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma |
Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |