Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer (CHORINE)
|Ovarian Neoplasms||Procedure: Cytoreductive Surgery and HIPEC Procedure: CRS alone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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.|
- Disease free survival [ Time Frame: 2 years ]
- postoperative morbidity and mortality [ Time Frame: 1 and 6 months ]
- Time to Chemotherapy [ Time Frame: 3 months ]percentage of patients in both arms completing the scheduled postoperative chemotherapy and time elapsed to start postoperative chemotherapy
- Overall Survival [ Time Frame: 1, 3 and 5 years ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Active Comparator: CRS + HIPEC
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy with CDDP+Paclitaxel
Procedure: Cytoreductive Surgery and HIPEC
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.
Active Comparator: CRS alone
Cytoreductive Surgery alone
Procedure: CRS alone
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.)
Eligible: Female adult women (18 to 70 years old) patients, with epithelial ovarian/tubal (FIGO stage IIIC) with a Fagotti modified Laparoscopic Scoring System ≥ 4 who will show a complete or partial clinical response(RECIST 1.1) after 3 cycles of neoadjuvant chemotherapy (Carboplatin+Paclitaxel).
Duration of recruitment: 2 years. Sample size has been calculated to reach a confidence level of 95% with a power of 80%, considering a 45% and 75% disease-free survival at 2 years in CRS and CRS+HIPEC group respectively.
Sample size will be 47 patients for each group. After CRS, only patients with adequate cytoreduction (CC 0-1, residual tumor ≤ 2.5mm) will be randomized. Patients with suboptimal cytoreduction (CC 2-3, residual tumor > 2.5mm) are not suitable for randomization.
The drug schedule elected in the current study is 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. Primary Endpoint: 2-years disease-free survival.
1-year, 3- and 5-years disease-free survival;
1 month, 1-year, 3- and 5-years overall survival; toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity; duration of operation; return of bowel function; length of hospital stay; return to normal activity; six months and one year QOL, using the SF-36 v1.0; percentage of patients in both arms completing the scheduled postoperative chemotherapy; Subgroup analysis: PCI ≤ 15; pts. ≤ 40yrs.
Main topics of this Study:
Focused only on upfront treatment of primary disease. Select platinum-sensible patients (responders to platinum-based neoadjuvant chemotherapy).
Take advantage of NACT to maximize chances for cytoreduction. Standardized strategy for 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.). Pelvic and peri-aortic lymphadenectomy is not chosen as standard procedure, but should warrant adequate staging.
Compare only the effect of HIPEC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628380
|Contact: Luca Ansaloni, MDfirstname.lastname@example.org|
|Contact: Marco Lotti, MDemail@example.com|
|Jena University Hospital||Recruiting|
|Jena, Germany, 07743|
|Contact: Ingo B. Runnebaum, MD, MBA INGO.RUNNEBAUM@med.uni-jena.de|
|Principal Investigator: Ingo B. Runnebaum, MD, MBA|
|A.O. Papa Giovanni XXIII (former Ospedali Riuniti)||Recruiting|
|Bergamo, Bg, Italy, 24128|
|Contact: Luca Ansaloni, MD +390352673477 firstname.lastname@example.org|
|Contact: Marco Lotti, MD +390352673477 email@example.com|
|Principal Investigator: Luca Ansaloni, MD|
|A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna - Bologna (Bo)||Recruiting|
|Bologna, Bo, Italy, 40138|
|Contact: Pierandrea Deiaco, MD +390516364426 firstname.lastname@example.org|
|Principal Investigator: Pierandrea Deiaco, MD|
|A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica||Recruiting|
|Parma, Pr, Italy, 43100|
|Contact: Fausto Catena, MD +390521703940 email@example.com|
|Principal Investigator: Fausto Catena, MD|
|POLICLINICO UNIVERSITARIO GEMELLI DI ROMA - ROMA (RM) GINECOLOGIA E OSTETRICIA Dipartimento per la Tutela della Salute della Donna e della Vita Nascente||Recruiting|
|Roma, Italy, 00168|
|Contact: Giovanni Scambia, MD +390630156279 firstname.lastname@example.org|
|Principal Investigator: Giovanni Scambia, MD|
|Principal Investigator:||Luca Ansaloni, MD||A.O. Ospedale Papa Giovanni XXIII|