Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00008112|
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 5, 2003
Last Update Posted : August 7, 2013
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|
- 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 Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008112
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|University Hospital - Rotterdam Dijkzigt|
|Rotterdam, Netherlands, 3000 CA|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Study Chair:||Anneke M. Westermann, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|