Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

NCT04282356 | Recruiting Phase 2 DMC

• 1 other identifier: PROICM 2019-08 INT
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Intraperitoneal Chemotherapy

Keywords

ovarian cancer; intraperitoneal; chemotherapy; surgery; HIPEC

Outcome Measures

Primary Outcomes (2)

• The success of the combination of HIPEC and IPC assessed by chemotherapy administration after surgery

  Number of administred courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC.

  Until the chemotherapy courses completion: 6 months after interval surgery

• The success of HIPEC and IPC combination assessed by surveillance safety

  Rate of HIPEC tolerance (deterioration of the renal function and morbidity of HIVEC) and CIP tolerance (abdomibal pain and complications of the IP treatment)

  Until the chemotherapy courses completion: 6 months after interval surgery

Secondary Outcomes (5)

• Morbidity rate of reductive surgery combined with HIPEC according to the CLAVIEN and DINDO score

  Up to 60 postoperative days

• HIPEC toxicities

  2 months after interval surgery

• IPC toxicities

  Until the chemotherapy courses completion: 6 months after interval surgery

• Complications

  after interval surgery with HIPE: 2 months

• Relapse-Free survival

  Until study completion: 5 years

Study Arms (1)

Intraperitoneal chemotherapy

EXPERIMENTAL

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

Interventions

Intraperitoneal chemotherapy during surgery DRUG

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).

Also known as: Intraperitoneal chemotherapy after surgery

Intraperitoneal chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Related Publications (4)

• Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29. doi: 10.1056/NEJMra041842. No abstract available.

  PMID: 15590954 BACKGROUND

• Colombo PE, Mourregot A, Fabbro M, Gutowski M, Saint-Aubert B, Quenet F, Gourgou S, Rouanet P. Aggressive surgical strategies in advanced ovarian cancer: a monocentric study of 203 stage IIIC and IV patients. Eur J Surg Oncol. 2009 Feb;35(2):135-43. doi: 10.1016/j.ejso.2008.01.005. Epub 2008 Mar 4.

  PMID: 18289825 BACKGROUND

• Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.

  PMID: 16394300 BACKGROUND

• van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.

  PMID: 29342393 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Philippe ROUANET, MD

  Institut Régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION

CONTACT

0467613102; DRCI-icm105@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 24, 2020
• Study Start: September 15, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)