Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer (CHORINE)
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|ClinicalTrials.gov Identifier: NCT01628380|
Recruitment Status : Recruiting
First Posted : June 26, 2012
Last Update Posted : August 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Procedure: Cytoreductive Surgery and HIPEC Procedure: CRS alone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||July 2018|
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.)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628380
|Contact: Luca Ansaloni, MDemail@example.com|
|Contact: Marco Lotti, MDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Marco Lotti, MD +390352673477 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Pierandrea Deiaco, MD|
|A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica||Recruiting|
|Parma, Pr, Italy, 43100|
|Contact: Fausto Catena, MD +390521703940 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Giovanni Scambia, MD|
|Principal Investigator:||Luca Ansaloni, MD||A.O. Ospedale Papa Giovanni XXIII|