Etude : CHIPOR /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : CHIPOR

Situation thérapeutique : Néoadjuvant

Traitement : Chirurgie

Cadre réglementaire : RIPH2

Dernière MÀJ : 19/01/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude randomisée de phase III évaluant la Chimiothérapie Hyperthermique Intra–Péritonéale dans le traitement du cancer de l‘Ovaire en Récidive

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire
Informations complémentaires
Schéma : A Phase III Randomized Study of Phase III Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

2 arms:
- Active Comparator: maximal cytoreductive surgery without HIPEC
- Experimental: maximal cytoreductive surgery with HIPEC

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.

Phase : III

Stade : Localisé à Localement avancé

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient age ≥ 18 yrs,
- Performance Status OMS < 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 et ALAT ≤ 3 time the Upper Normal Limit,
- No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance >60 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- Critères de non-inclusion

Critères de non-inclusion : - 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.
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
3, avenue du Général Harris
14000 CAEN

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :
Florence JOLY


Statut de l'essai : CLOS

MAJ : 06/01/2021