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NCT04282356RecruitingPhase 2

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Combining Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Postoperative Intraperitoneal Chemotherapy (IPC)

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
55 (estimated)
First submitted
8 Jan 2020
Start date
15 Sept 2020
Primary completion date
Dec 2026
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT number
NCT04282356
EU CT number
2024-515339-30-00
EudraCT number
2019-003357-29

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 55
  • From 15 Sept 2020 to the primary completion date, Dec 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient who has already been treated with chemo-hyperthermia for ovarian cancer,

Other illness

  • General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
  • Serious life-threatening co-existing condition at stake,
  • 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,

Lab values

  • Renal impairment (clearance \<70 ml / min) according to the MDRD method,
  • Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal),

Other

  • 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),
  • Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Institut Regional Du Cancer De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceNot yet recruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceNot yet recruiting
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.