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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01506856
Eligibility Criteria:
Inclusion Criteria:
1. Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
2. Patients scheduled to undergo laparotomy
\*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
3. ECOG Performance Status: 0-2
4. Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
5. Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
6. Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
* Neutrophil count ≧ 1,500 /mm3
* Platelet count ≧ 100,000 /mm3
* AST (GOT) ≦ 100 IU/L
* ALT (GPT) ≦ 100 IU/L
* Total bilirubin \< 1.5 mg/dL
* Serum Creatinine \< 1.5 mg/dL
* Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention
* Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4.0)
7. Patients expected to survive longer than 3 months from the start date of the protocol treatment
8. Patients aged 20 years and older at the time of tentative registration (with no upper age limit)
9. Patients who provide written informed consent for participation in this trial
Exclusion Criteria:
1. Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
2. Patients who have received previous chemotherapy or radiation therapy to treat the current disease
3. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
4. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
5. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
6. Patients with a pleural effusion requiring continuous drainage
7. Patients with an active infection requiring antibiotics
8. Patients who are pregnant, nursing or of child-bearing potential
9. Patients with evidence upon physical examination of brain tumor and any brain metastases
10. Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
11. Patients with any signs/symptoms of interstitial pneumonia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT01506856
Study Brief:
Protocol Section:
NCT01506856