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Trial record 1 of 1 for:    chipor | France
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Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment (CHIPOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01376752
Recruitment Status : Suspended (Temporary suspension since March 20th 2020 due to COVID-19 pandemic)
First Posted : June 20, 2011
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Procedure: Maximal cytoreductive surgery Drug: HIPEC Phase 3

Detailed Description:

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

  • either treatment A = maximal cytoreductive surgery without HIPEC
  • or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
Actual Study Start Date : April 2011
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : April 2025


Arm Intervention/treatment
Active Comparator: maximal cytoreductive surgery without HIPEC
The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery

Experimental: maximal cytoreductive surgery with HIPEC
The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery

Drug: HIPEC
HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²




Primary Outcome Measures :
  1. overall survival [ Time Frame: from randomization to death (up to 4 years) ]
    Follow-up of 4 years.


Secondary Outcome Measures :
  1. relapse free survival [ Time Frame: from randomization to relapse (up to 4 years) ]
    Follow-up of 4 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age ≥ 18 years
  • Performance Status WHO < 2
  • Initially treated for Epithelial Ovarian Carcinoma
  • Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
  • Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
  • Complete cytoreductive surgery
  • The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
  • No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
  • No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
  • Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
  • No contraindication to general anaesthesia for heavy surgery
  • Patients having read, signed and dated Informed consent before any study procedure
  • Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment

Exclusion Criteria:

  • Patient age <18 years
  • Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
  • Hypersensitivity to Platinum compound
  • Distant metastasis
  • Use of anti-angiogenic treatment
  • Patient with other concurrent severe life threatening disease
  • The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
  • Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
  • Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker > CC1)
  • Early relapse: less than 6 mois after the end of the first treatment
  • Ovarian tumor other than Epithelioma Ovarian Cancer
  • Uncontrolled infection
  • Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC
  • Patient already treated with HIPEC for the ovarian cancer
  • Individual deprived of liberty or placed under the authority of a tutor

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): NCT01376752


Locations
Show Show 33 study locations
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Jean-Marc CLASSE Centre rené Gauducheau, NANTES
Publications of Results:
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01376752    
Other Study ID Numbers: FEDEGYN 02 / 0410-CHIPOR
2010-023035-42 ( EudraCT Number )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type