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Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer (INTENS-IP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282356
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Intraperitoneal Chemotherapy Drug: Intraperitoneal chemotherapy during surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Combining Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Postoperative Intraperitoneal Chemotherapy (IPC)
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Intraperitoneal chemotherapy
Cisplatin 100mg/m2 during surgery IV Paclitaxel, 135mg/m2 on D1, IP Carboplatin, AUC 6 on D1, and IP Paclitaxel, 60mg/m2 on D8 after surgery with at least 3 courses performed (up to 4-6 allowed)
Drug: Intraperitoneal chemotherapy during surgery
During interval surgery the patient will undergo HIPEC (Cisplatin 100mg/m2, 1h 30 infusions with sodium thiosulfate renal protection). They will then receive postoperative IPC i.e intravenous and intraperitoneal administration (IV Paclitaxel, 135mg/m2 on D1, IP Carboplatin, AUC 6 on D1, and IP Paclitaxel, 60mg/m2 on D8) with at least 3 courses performed (up to 4-6 allowed).
Other Name: Intraperitoneal chemotherapy after surgery




Primary Outcome Measures :
  1. The success of the combination of HIPEC and IPC assessed by chemotherapy administration after surgery [ Time Frame: Until the chemotherapy courses completion: 6 months after interval surgery ]
    Number of administred courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC.

  2. The success of HIPEC and IPC combination assessed by surveillance safety [ Time Frame: Until the chemotherapy courses completion: 6 months after interval surgery ]
    Rate of HIPEC tolerance (deterioration of the renal function and morbidity of HIVEC) and CIP tolerance (abdomibal pain and complications of the IP treatment)


Secondary Outcome Measures :
  1. Morbidity rate of reductive surgery combined with HIPEC according to the CLAVIEN and DINDO score [ Time Frame: Up to 60 postoperative days ]
    Morbidity rate according to the CLAVIEN and DINDO score

  2. HIPEC toxicities [ Time Frame: 2 months after interval surgery ]
    according to the CTC-AE v5.0 scale

  3. IPC toxicities [ Time Frame: Until the chemotherapy courses completion: 6 months after interval surgery ]
    according to the CTC-AE v5.0 scale

  4. Complications [ Time Frame: after interval surgery with HIPE: 2 months ]
    Complications due to intraperitoneal catheters

  5. Relapse-Free survival [ Time Frame: Until study completion: 5 years ]
    Relapse Free Survival is defined as the time from the date of inclusion to first documentation of objective tumor progression or to death due to progression



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 to 75 years,
  • Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer,
  • Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
  • Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm),
  • Complete interval cytoreduction surgery,
  • Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination,
  • The delay between the last course of NAT and the surgery must be between 4 and 8 weeks,
  • Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 109 / L, platelets ≥ 100 x 109 / L,
  • Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN,
  • Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method,
  • Informed consent signed before any specific procedure under consideration,
  • Patients affiliated to the French social security scheme or equivalent.

Exclusion Criteria:

  • Performance Index (WHO) ≥ 2,
  • Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm),
  • Renal impairment (clearance <70 ml / min) according to the MDRD method,
  • General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
  • Hepatic insufficiency (bilirubin > 1.5 x normal, ASAT & ALAT > 3 x upper limit of normal),
  • Serious life-threatening co-existing condition at stake,
  • Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
  • Patient who has already been treated with chemo-hyperthermia for ovarian cancer,
  • History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial,
  • Any severe untreated infectious disease,
  • Peripheral sensory neuropathy ≥ grade 2 at the inclusion time,
  • Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons,
  • Pregnant and / or nursing women,
  • Subjects under tutelage, curatorship or safeguard of justice.

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): NCT04282356


Contacts
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Contact: Jean-Pierre BLEUSE, MD 0467612344 ext +33 DRCI-icm105@icm.unicancer.fr

Locations
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France
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Direction Générale de l'Offre de Soins
Investigators
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Study Chair: Philippe ROUANET, MD Institut Régional du Cancer de Montpellier (ICM)
Publications:
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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04282356    
Other Study ID Numbers: PROICM 2019-08 INT
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
ovarian cancer
intraperitoneal
chemotherapy
surgery
HIPEC
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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