Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00045461
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer
* Recurrent disease (any FIGO stage)
* Not amenable to curative surgery or radiotherapy alone
* Failed prior primary platinum-based therapy at least 6 months after therapy discontinuation
* Measurable lesion by CT scan, MRI, chest x-ray, or sonography
* Physical examination allowed for documenting lymph node and skin metastases
* Physical gynecological examination allowed for well-defined palpable tumor lesions
* Increase in CA 125 without any measurable tumor is not acceptable as indication of recurrence
* No CNS metastases
* No tumor of borderline malignancy
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* ECOG 0-2
Life expectancy
* At least 24 weeks
Hematopoietic
* Neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic
* Not specified
Renal
* Creatinine clearance at least 60 mL/min
* No chronic or acute renal failure
Cardiovascular
* Cardiovascular function sufficient for hyperthermia treatment by stress-ECG
* No cardiomyopathy with impaired ventricular function
* No New York Heart Association class III or IV heart disease
* No cardiac arrhythmias influencing LVEF and requiring medication
* No myocardial infarction or angina pectoris within the past 6 months
* No uncontrolled arterial hypertension
Pulmonary
* Pulmonary function sufficient for hyperthermia treatment by pulmonary function tests
Other
* No untreated endocrinological disease (e.g., hyperthyroidism or diabetes mellitus)
* No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
* No contraindication against hyperthermia treatment (e.g., photodermatosis, history of malignant hyperthermia, or claustrophobia)
* No hypersensitivity to carboplatin, ifosfamide, or any other study medication
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No concurrent cytotoxic or other antineoplastic therapy
Endocrine therapy
* Concurrent hormone replacement therapy allowed
* Concurrent steroid antiemetics allowed
Radiotherapy
* See Disease Characteristics
* At least 1 year since prior radiotherapy (tumoricidal dose) of the pelvis
* Concurrent palliative local radiotherapy for painful (nonprogressive) existing lesion is allowed if other measurable sites are present
* No concurrent radiotherapy to a second existing lesion
Surgery
* See Disease Characteristics
Other
* No prior form of hyperthermic therapy
* At least 3 weeks since other medications as part of another clinical study
* At least 3 weeks since prior investigational agents
* At least 6 weeks since prior betablockers
* No concurrent photosensitizing drugs
* No concurrent betablockers
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00045461
Study Brief:
Protocol Section:
NCT00045461