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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by A.O. Ospedale Papa Giovanni XXIII
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
ClinicalTrials.gov Identifier:
NCT01628380
First received: June 22, 2012
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Ovarian Neoplasms
Procedure: Cytoreductive Surgery and HIPEC
Procedure: CRS alone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative morbidity and mortality [ Time Frame: 1 and 6 months ] [ Designated as safety issue: Yes ]
  • Time to Chemotherapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
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)
Arms Assigned Interventions
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.)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628380

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

Locations
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
Principal Investigator: Luca Ansaloni, MD A.O. Ospedale Papa Giovanni XXIII
  More Information

Publications:
Responsible Party: Luca Ansaloni MD, MD, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT01628380     History of Changes
Other Study ID Numbers: CHORINE 2012-002616-22
Study First Received: June 22, 2012
Last Updated: August 27, 2014
Health Authority: Italy: CLIOSS
Italy: Ethics Committee Ospedali Riuniti di Bergamo

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
HIPEC
Ovarian Cancer
Cytoreductive Surgery

Additional relevant MeSH terms:
Fever
Ovarian Neoplasms
Adnexal Diseases
Body Temperature Changes
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Signs and Symptoms
Urogenital Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014