First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
AICE
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)
2 other identifiers
interventional
215
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 19, 2016
December 1, 2016
6.4 years
August 8, 2012
December 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month disease non-progression rate
12 months
Secondary Outcomes (5)
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
Study Arms (2)
Regimen B, PEip and TCiv therapy
EXPERIMENTALWeekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Regimen A: Standard TCiv therapy
ACTIVE COMPARATORIV paclitaxel plus carboplatin or docetaxel plus carboplatin
Interventions
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
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Gynecologic Oncology Grouplead
- Fudan Universitycollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
- Shanghai Zhongshan Hospitalcollaborator
Study Sites (7)
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi Cancer Hospital
Wuxi, Jiangsu, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030, China
Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Fudan University Cancer Hospital
Shanghai, 200032, China
Related Publications (1)
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.
PMID: 31383985DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rongyu Zang, MD,PhD
Shanghai Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 20, 2012
Study Start
April 1, 2009
Primary Completion
September 1, 2015
Study Completion
July 1, 2016
Last Updated
December 19, 2016
Record last verified: 2016-12