Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Ovarian Cancer, intraperitoneal chemotherapy
Brief summary
The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
Detailed description
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.
Interventions
DRUGPEip (weekly) and TCiv
IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
DRUGTCiv
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Sponsors
Fudan University
Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Shanghai Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years to ≤ 75 years. * Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone * Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm * Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection. * ECOG performance 0-2. * No more than 3 cycles of chemotherapy prior to surgery. * Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin \< 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min. * Comply with intraperitoneal chemotherapy and follow-up. * Written informed consent.
Exclusion criteria
* Low-malignant potential ovarian tumor. * Laboratory testing insufficiency. Hemoglobin \< 10 g/dL. Renal insufficiency with serum creatinine \> 1.6. * Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3. * Active infection. * Clinically significant gastrointestinal abnormalities. * Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure. * Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up. * Prior invasive malignancies within the last 5 years showing activity of disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month disease non-progression rate | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | up to 120 months |
| Completion rate of intraperitoneal chemotherapy. | up to 6 months |
| Quality of life assessments | baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy. |
| Overall Survival | up to 120 months |
| adverse effects | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
Countries
China
Outcome results
None listed