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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00178802 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast, Endometrial, Cervical and Ovarian Cancers
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Scientific title:
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Phase II Study of Mild Whole Body Hyperthermia Combined With 5-Fluorouracil/Interferon-a/Liposomal Doxorubicin in Patients With Advanced Malignancy |
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Date of first enrolment:
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June 1996 |
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Target sample size:
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24 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00178802 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Joan M Bull, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Resistant breast, endometrial, cervix, or ovarian cancer
- No active metastasis to the brain
- No more than 8 previous regimes of Doxil
- Successful completion of preliminary function tests
- Good ECOG score
Exclusion Criteria:
- Active metastasis to the brain
- 8 or more previous cycles of Doxil
- Poor completion of preliminary function tests
- Poor ECOG score
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Cervix Neoplasms
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Endometrial Neoplasms
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Ovarian Neoplasms
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Intervention(s)
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Other: thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)
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Primary Outcome(s)
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Response duration
[Time Frame: 5 years]
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Tumor response
[Time Frame: 5 years]
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Secondary Outcome(s)
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Toxicity
[Time Frame: 5 years]
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Secondary ID(s)
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HSC-MS-01-111
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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