Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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),
Trial design
Design model
Single group
Treatments tested in this trial
Intraperitoneal chemotherapy during surgery
DrugDuring 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).
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Intraperitoneal chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Until the chemotherapy courses completion: 6 months after interval surgery2
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)
Time frame
Until the chemotherapy courses completion: 6 months after interval surgerySecondary outcomes
1
Morbidity rate of reductive surgery combined with HIPEC according to the CLAVIEN and DINDO score
Morbidity rate according to the CLAVIEN and DINDO score
Time frame
Up to 60 postoperative days2
HIPEC toxicities
according to the CTC-AE v5.0 scale
Time frame
2 months after interval surgery3
IPC toxicities
according to the CTC-AE v5.0 scale
Time frame
Until the chemotherapy courses completion: 6 months after interval surgery4
Complications
Complications due to intraperitoneal catheters
Time frame
after interval surgery with HIPE: 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut du Cancer de Montpellier - Val d'Aurelle
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov