Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer
CHORINE
Stage IIIC Unresectable Epithelial Ovarian/Tubal Cancer With Partial or Complete Response After 1st Line Neoadjuvant Chemotherapy (3 Cycles CBDCA+Paclitaxel): a Phase 3 Prospective Randomized Study Comparing Cytoreductive Surgery + Hyperthermic Intraperitoneal Chemotherapy (CDDP+Paclitaxel) + 3 Cycles CBDCA+Paclitaxel vs Cytoreductive Surgery Alone + 3 Cycles CBDCA+Paclitaxel.
1 other identifier
interventional
94
2 countries
5
Brief Summary
Aim of the Study is to compare two-years disease-free survival of Cytoreductive Surgery (CRS) and Hyperthermic IntraPEritoneal Chemotherapy (HIPEC, CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
Longer than P75 for phase_3
5 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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 28, 2014
August 1, 2014
6 years
June 22, 2012
August 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
2 years
Secondary Outcomes (3)
postoperative morbidity and mortality
1 and 6 months
Time to Chemotherapy
3 months
Overall Survival
1, 3 and 5 years
Study Arms (2)
CRS + HIPEC
ACTIVE COMPARATORCytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy with CDDP+Paclitaxel
CRS alone
ACTIVE COMPARATORCytoreductive Surgery alone
Interventions
CRS: radical surgery, associated to any surgical procedure needed to obtain a zero or ≤ 0.25cm residual tumor (peritonectomy, bowel resection, diaphragmatic stripping, gastric resection, etc.). HIPEC: Cisplatin (CDDP) (100 mg/m2 of body surface area) + Paclitaxel (175mg/m2 of body surface area). Closed/open technique, as preferred. Duration: 90 minutes. Mean Intra-abdominal Temperature: 42°C.
CRS: radical surgery, associated to any surgical procedure needed to obtain a zero or ≤ 0.25cm residual tumor (peritonectomy, bowel resection, diaphragmatic stripping, gastric resection, etc.)
Eligibility Criteria
You may qualify if:
- Female adult women (18 to 70 years old) patients, with EOC (FIGO stage IIIc) with a Fagotti modified Laparoscopic Scoring System ≥ 4 who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy;
- performance status (ECOG) 0, 1 or 2;
- signed informed consent.
You may not qualify if:
- refusing to sign an informed consent;
- age \> 70 years and age \<18 years;
- BMI \> 35;
- impossibility of an adequate follow-up;
- presence of other active neoplasms;
- active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol;
- extraabdominal metastases (Stage IV) ;
- performance status (ECOG)\>2;
- complete bowel obstruction;
- Abnormal bone marrow indices or renal and liver function;
- ASA IV or V.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Jena University Hospital
Jena, 07743, Germany
A.O. Papa Giovanni XXIII (former Ospedali Riuniti)
Bergamo, Bg, 24128, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna - Bologna (Bo)
Bologna, Bo, 40138, Italy
A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica
Parma, Pr, 43100, Italy
POLICLINICO UNIVERSITARIO GEMELLI DI ROMA - ROMA (RM) GINECOLOGIA E OSTETRICIA Dipartimento per la Tutela della Salute della Donna e della Vita Nascente
Roma, Roma, 00168, Italy
Related Publications (1)
Ansaloni L, De Iaco P, Frigerio L. Re: "cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: multi-institutional phase II trial." - Proposal of a clinical trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in advanced ovarian cancer, the CHORINE study. Gynecol Oncol. 2012 Apr;125(1):279-81. doi: 10.1016/j.ygyno.2012.01.001. Epub 2012 Jan 9. No abstract available.
PMID: 22233688BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Ansaloni, MD
A.O. Ospedale Papa Giovanni XXIII
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 26, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
August 28, 2014
Record last verified: 2014-08