Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

NAActive, not recruitingINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

October 19, 2018

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2028

Conditions
Ovarian Cancer Stage IVOvarian Cancer Stage IIICOvarian Cancer Stage IIIb
Interventions
PROCEDURE

Retarded IDS (Interval Debulking Surgery)

"Patient will receive 6 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C6D1. After surgery patient will undergo 2 more courses of carboplatine and paclitaxel chemotherapy~Treatment accepted :~Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):~* paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or~* paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or~* paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21~* Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)"

PROCEDURE

Standard IDS (Interval Debulking Surgery)

"Patient will receive 3 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C3D1. After surgery patient will undergo 5 more courses of carboplatine and paclitaxel chemotherapy.~Treatment accepted :~Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):~* paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or~* paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or~* paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21~* Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)"

Trial Locations (29)

13008

Hôpital Saint-Joseph, Marseille

14000

Centre François Baclesse, Caen

14033

Centre Hospitalier Universitaire Caen, Caen

21079

Centre Georges François Leclerc, Dijon

29200

CHU de BREST - Hôpital Cavale Blanche, Brest

31059

Institut Claudius Regaud, Toulouse

33076

Institut Bergonié, Bordeau

34298

ICM Val d'Aurelle, Montpellier

37000

Centre Hospitalier Universitaire Bretonneau, Tours

38043

CHU Grenoble-Alpes - Site Nord (La Tronche), Grenoble

44093

Centre Hospitalier Universitaire de Nantes-Hôpital Mère et Enfant, Nantes

44202

Hôpital Privé du Confluent, Nantes

44805

ICO Centre René Gauducheau, Saint-Herblain

51056

Institut Jean Godinot, Reims

56100

Hôpital du Scorff, Lorient

63000

Centre Jean Perrin, Clermont-Ferrand

69110

Clinique Médico-chirurgicale CHARCOT, Sainte-Foy-lès-Lyon

69373

Centre Léon Bérard, Lyon

72000

Centre Jean Bernard - Clinique Victor Hugo, Le Mans

75014

Hôpital Cochin, Paris

75015

Hôpital Européen Georges Pompidou, Paris

75651

Groupe Hospitalier Pitié Salpétrière, Paris

84000

ICA - Polyclinique Urbain V, Avignon

86021

Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers, Poitiers

87000

CHU de Limoges - Hôpital de la Mère et de l'Enfant, Limoges

92210

Hôpital René Huguenin, Institut Curie, Saint-Cloud

94805

Gustave Roussy, Villejuif

95602

Hôpital Simone Veil, Eaubonne

06189

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

ARCAGY/ GINECO GROUP

OTHER

NCT03579394 - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer | Biotech Hunter | Biotech Hunter