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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02244502
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
2. Recurrent ovarian cancer with any number of prior therapies
3. 18 years of age and older
4. Life expectancy of at least 12 weeks
5. Measurable disease according to the revised RECIST criteria version 1.1. A lesion in a previously irradiated field is considered "non-measurable" and cannot be a "target lesion".
6. ECOG score 0-1 (see Appendix A)
7. Adequate bone marrow, liver and renal functions:
1. Absolute neutrophil count ≥ 1.5 x 10 9/L
2. Platelet count ≥ 100 x 10 9/L
3. Hemoglobin ≥ 10 g/dL
4. AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient has documented liver metastases
5. Bilirubin ≤1.5 x ULN
6. Serum creatinine ≤ 1.5 x ULN
7. Coagulation status: PT and PTT within normal limits or within therapeutic limits for patients receiving anticoagulation.
8. Able to operate the NovoTTF-100L(O) System independently or with the help of a caregiver
9. No concurrent anti-tumor therapy (beyond weekly paclitaxel and NovoTTF Therapy as per protocol)
10. At least 4 weeks since major surgery
Exclusion Criteria:
1. Meningeal carcinomatosis or known brain metastases which have not been treated, require steroid treatment, or are symptomatic.
2. Any other malignancy requiring anti-tumor treatment in the past three years, except resected non-melanomatous skin cancer, breast carcinoma in situ, adequately treated stage I breast cancer or in situ cervical cancer.
3. Chemotherapy within 4 weeks prior to treatment start.
4. Radiotherapy within 4 weeks prior to treatment start.
5. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
1. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
2. History of arrhythmia that is symptomatic or requires treatment. Patients with stable atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
3. Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
4. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.
6. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
7. Known history of sensitivity to taxanes or drugs containing Cremophor
8. Grade 2 or greater peripheral neuropathy
9. Known allergies to medical adhesives or hydrogel
10. Pregnant or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02244502
Study Brief:
Protocol Section:
NCT02244502