Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer

NCT ID: NCT01628380

Last Updated: 2014-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-07-31

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).

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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRS + HIPEC

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy with CDDP+Paclitaxel

Group Type: ACTIVE_COMPARATOR

Cytoreductive Surgery and HIPEC

Intervention Type: PROCEDURE

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 alone

Cytoreductive Surgery alone

Group Type: ACTIVE_COMPARATOR

CRS alone

Intervention Type: PROCEDURE

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.)

Interventions

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.

Intervention Type: 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.)

Intervention Type: PROCEDURE

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinical Organization for Strategies & Solutions (CLIOSS), former Nerviano Medical Sciences (http://www.nervianoms.com/en/)

UNKNOWN

Sponsor Role: collaborator

Onlus Cancro Primo Aiuto (http://www.cpaonlus.it/)

UNKNOWN

Sponsor Role: collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role: lead

Responsible Party

Luca Ansaloni MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Ansaloni, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale Papa Giovanni XXIII

Locations

Jena University Hospital

Jena, , Germany

Site Status: RECRUITING

A.O. Papa Giovanni XXIII (former Ospedali Riuniti)

Bergamo, Bg, Italy

Site Status: RECRUITING

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna - Bologna (Bo)

Bologna, Bo, Italy

Site Status: RECRUITING

A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica

Parma, Pr, Italy

Site Status: RECRUITING

POLICLINICO UNIVERSITARIO GEMELLI DI ROMA - ROMA (RM) GINECOLOGIA E OSTETRICIA Dipartimento per la Tutela della Salute della Donna e della Vita Nascente

Roma, Roma, Italy

Site Status: RECRUITING

Countries

Germany; Italy

Central Contacts

Luca Ansaloni, MD

Role: CONTACT

lansaloni@hpg23.it

+390352673477

Marco Lotti, MD

Role: CONTACT

mlotti@hpg23.it

+390352673477

Facility Contacts

Ingo B. Runnebaum, MD, MBA

Role: primary

INGO.RUNNEBAUM@med.uni-jena.de

Luca Ansaloni, MD

Role: primary

lansaloni@hpg23.it

+390352673477

Marco Lotti, MD

Role: backup

mlotti@hpg23.it

+390352673477

Pierandrea Deiaco, MD

Role: primary

pierandrea.deiaco@aosp.bo.it

+390516364426

Fausto Catena, MD

Role: primary

faustocatena@gmail.com

+390521703940

Giovanni Scambia, MD

Role: primary

clinicaltrials@rm.unicatt.it

+390630156279

References

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.

Reference Type: BACKGROUND

PMID: 22233688 (View on PubMed)

Other Identifiers

CHORINE 2012-002616-22

Identifier Type: -

Identifier Source: org_study_id