CHORINE: Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Secondary Endpoints:
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.)
|
Outcome Measures
Primary Outcome Measures
- Disease free survival [2 years]
Secondary Outcome Measures
- postoperative morbidity and mortality [1 and 6 months]
- Time to Chemotherapy [3 months]
percentage of patients in both arms completing the scheduled postoperative chemotherapy and time elapsed to start postoperative chemotherapy
- Overall Survival [1, 3 and 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
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refusing to sign an informed consent;
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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;
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extraabdominal metastases (Stage IV) ;
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performance status (ECOG)>2;
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complete bowel obstruction;
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Abnormal bone marrow indices or renal and liver function;
-
ASA IV or V.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jena University Hospital | Jena | Germany | 07743 | |
| 2 | A.O. Papa Giovanni XXIII (former Ospedali Riuniti) | Bergamo | Bg | Italy | 24128 |
| 3 | A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna - Bologna (Bo) | Bologna | Bo | Italy | 40138 |
| 4 | A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica | Parma | Pr | Italy | 43100 |
| 5 | POLICLINICO UNIVERSITARIO GEMELLI DI ROMA - ROMA (RM) GINECOLOGIA E OSTETRICIA Dipartimento per la Tutela della Salute della Donna e della Vita Nascente | Roma | Italy | 00168 |
Sponsors and Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Clinical Organization for Strategies & Solutions (CLIOSS), former Nerviano Medical Sciences (http://www.nervianoms.com/en/)
- Onlus Cancro Primo Aiuto (http://www.cpaonlus.it/)
Investigators
- Principal Investigator: Luca Ansaloni, MD, A.O. Ospedale Papa Giovanni XXIII
Study Documents (Full-Text)
None provided.More Information
Publications
- CHORINE 2012-002616-22