Clinical trial NCT01669226: First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
Official title: A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bulky Stage IIIC and IV Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Ovarian Cancer
intraperitoneal chemotherapy
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Fudan University
name: Shanghai Jiao Tong University School of Medicine
name: Shanghai Zhongshan Hospital
First posted: 2012-08-20
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-month disease non-progression rate
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 120 months
measure: Completion rate of intraperitoneal chemotherapy.
timeFrame: up to 6 months
measure: Quality of life assessments
timeFrame: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
measure: Overall Survival
timeFrame: up to 120 months
measure: adverse effects
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Shanghai Gynecologic Oncology Group
name: Rongyu Zang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6.