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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 : Unknown
Verified August 2014 by Luca Ansaloni MD, A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Recruiting
First Posted : June 26, 2012
Last Update Posted : August 28, 2014
Sponsor:
Collaborators:
Clinical Organization for Strategies & Solutions (CLIOSS), former Nerviano Medical Sciences (http://www.nervianoms.com/en/)
Onlus Cancro Primo Aiuto (http://www.cpaonlus.it/)
Information provided by (Responsible Party):
Luca Ansaloni MD, A.O. Ospedale Papa Giovanni XXIII

Study Description
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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
Ovarian Neoplasms Procedure: Cytoreductive Surgery and HIPEC Procedure: CRS alone 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
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.
Study Start Date : June 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. postoperative morbidity and mortality [ Time Frame: 1 and 6 months ]
  2. 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

  3. Overall Survival [ Time Frame: 1, 3 and 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Luca Ansaloni, MD +390352673477 lansaloni@hpg23.it
Contact: Marco Lotti, MD +390352673477 mlotti@hpg23.it

Locations
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Germany
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         
Italy
A.O. Papa Giovanni XXIII (former Ospedali Riuniti) Recruiting
Bergamo, Bg, Italy, 24128
Contact: Luca Ansaloni, MD    +390352673477    lansaloni@hpg23.it   
Contact: Marco Lotti, MD    +390352673477    mlotti@hpg23.it   
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    pierandrea.deiaco@aosp.bo.it   
Principal Investigator: Pierandrea Deiaco, MD         
A.O. Universitaria Di Parma - Parma (Pr) Oncologia Chirurgica Recruiting
Parma, Pr, Italy, 43100
Contact: Fausto Catena, MD    +390521703940    faustocatena@gmail.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    clinicaltrials@rm.unicatt.it   
Principal Investigator: Giovanni Scambia, MD         
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
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Principal Investigator: Luca Ansaloni, MD A.O. Ospedale Papa Giovanni XXIII
More Information
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Publications:

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Responsible Party: Luca Ansaloni MD, MD, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT01628380    
Other Study ID Numbers: CHORINE 2012-002616-22
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Luca Ansaloni MD, A.O. Ospedale Papa Giovanni XXIII:
HIPEC
Ovarian Cancer
Cytoreductive Surgery
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders