Spots Global Cancer Trial Database for Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer
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Trial Identification
Brief Title: Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer
Official Title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum
Study ID: NCT01583322
Conditions
Study Description
Brief Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre Paul Papin, Angers, , France
Institut Ste Catherine, Avignon, , France
Clinique Tivoli, Bordeaux, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Hospitalier Alpes Leman, Contamine-sur-Arve, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Hospitalier de Dax, Dax, , France
Centre Georges François Leclerc, Dijon, , France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez, Lille, , France
Centre Oscar Lambret, Lille, , France
Centre Hospitalier Universitaire Dupuytren, Limoges, , France
Centre Léon bérard, Lyon, , France
ICM Val d'Aurelle, Montpellier, , France
Centre Catherine de Sienne, Nantes, , France
Hôpital Privé du Confluent S.A.S., Nantes, , France
Centre Antoine Lacassagne, Nice, , France
Centre Hospitalier Régional, Orléans, , France
Hôpital Cochin, Paris, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hôpital Tenon, Paris, , France
Institut Mutualiste Montsouris-Jourdan, Paris, , France
Centre Hospitalier Lyon-sud, Pierre-Bénite, , France
Milétrie - Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Institut Jean Godinot, Reims, , France
Centre Henri Becquerel, Rouen, , France
Clinique Armoricaine de Radiologie, Saint Brieuc, , France
Hôpital René Huguenin, Saint-Cloud, , France
ICO René Gauducheau, St Herblain, , France
Hôpital Civil, Strasbourg, , France
Hôpitaux Du Leman, Thonon-les-Bains, , France
Centre Claudius Régaud, Toulouse, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Gustave Roussy, Villejuif, , France
Contact Details
Name: Gwénaël Ferron, MD
Affiliation: Institut Claudius Régaud
Role: PRINCIPAL_INVESTIGATOR
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