A Phase 2/3 interventional study of carboplatin and ifosfamide in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 7 sites in 3 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by Ludwig-Maximilians - University of Munich · Phase 2/3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial, fallopian tube, or peritoneal cancer.
OBJECTIVES:
OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study.
Phase III (after successful treatment of 15 patients in phase II): Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years.
Patients are followed at 4 weeks and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's planned enrollment of 241 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer
Measurable lesion by CT scan, MRI, chest x-ray, or sonography
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Time to progressive disease
Response rate
Duration of response
Survival time
Effects on the presence of disseminated tumor cells in bone marrow
Toxicity
Quality of life
This study is status unknown, as verified in Oct 2002. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich