Tailored chemo regimens tested for frail ovarian cancer patients
NCT ID NCT02001272
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 120 vulnerable women over 70 with advanced ovarian cancer. It compared three chemotherapy plans: standard two-drug therapy every three weeks, a single drug every three weeks, or a weekly two-drug schedule. The goal was to see which plan allowed patients to complete six cycles without severe side effects or stopping early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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120 people
The number who actually took part.
- Started
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Dec 2013
- Finished
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Feb 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Woman \>70 year old * Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA \>25 and a radiological pelvic mass. * GVS (Geriatric Vulnerability Score) \>3. * Adequate bone marrow function including the following: Neutrophils ≥ 1.5 x 109/L , platelets ≥100 x 109/L and hemoglobin ≥9 g/dL. * Adequate glomerular filtration rate \>40 ml/min (estimates based on MDRD or Chatelut formula are sufficient) * No icterus. * Life expectancy \> 3 months. * Written informed consent obtained. * Covered by a Health System where applicable Exclusion Criteria: * Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * Prior history of chemotherapy. * Prior history of radiotherapy which may affect patient tolerability to chemotherapy. * Major perturbations of liver biology: Bilirubin \> 2 fold the upper normal limit (UNL), SGOT-SGPT \> 3 fold UNL. * Patient unable to be regularly followed for any reason (geographic, familial, social, psychologic). * Any mental or physical handicap at risk of interfering with the appropriate treatment. * Known allergy to Cremophor ® EL -containing drugs. * Any administrative or legal supervision where applicable
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Azienda Ulss 21 Legnago
Legnago, Italy
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Centre CARIO - Hôpital Privé des Côtes d'Armor
Plerin Sur Mer, 22190, France
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Centro di Riferimento Oncologico - CRO,IRCCS
Aviano, Italy
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Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy
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Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo
Torino, Italy
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Herlev Hospital
Herlev, Denmark
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Kuopio University Hospital
Kuopio, Finland
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Linköping University Hospital
Linköping, Sweden
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Notre-Dame Hospital of the CHUM
Montreal, Canada
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Ospedale Nuovo di Sassuolo
Sassuolo, Italy
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Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans
Orléans, 45067, France
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Service d''Hématologie Oncologie - Hôpital André Mignot
Le Chesnay, 78157, France
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Service d'Onco-Hématologie - Centre Antoine Lacassagne
Nice, 06186, France
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Service d'Onco-Hématologie - Hôpital Fleyriat
Bourg-en-Bresse, 01012, France
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Service d'Oncologie - Centre Hospitalier Alpes Leman
Contamines Sur Arve, 74130, France
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Service d'Oncologie - Centre Hospitalier de Chambéry
Chambéry, 73011, France
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Service d'Oncologie - Groupe Hospitalier Saint-Joseph
Paris, 75674, France
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Service d'Oncologie - Hôpital Cochin
Paris, 75014, France
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Service d'Oncologie - Hôpital Dupuytren
Limoges, 87042, France
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Service d'Oncologie Médicale - Centre Azuréen de Cancérologie
Mougins, 06250, France
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Service d'Oncologie Médicale - Centre Georges François Leclerc
Dijon, 21079, France
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Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll
Saint-Brieuc, 22015, France
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Service d'Oncologie Médicale - Centre Hospitalier d'Alès
Alès, 30100, France
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Service d'Oncologie Médicale - Centre Hospitalier de Cholet
Cholet, 49300, France
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Service d'Oncologie Médicale - Centre Hospitalier de Perpignan
Perpignan, 66046, France
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Service d'Oncologie Médicale - Centre Hospitalier de Sens
Sens, 89108, France
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Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000, France
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Service d'Oncologie Médicale - Centre Paul Strauss
Strasbourg, 67065, France
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Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc
Dijon, 21000, France
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Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, 44600, France
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Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis
Senlis, 60309, France
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Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou
Paris, 75908, France
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Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble
Grenoble, 38043, France
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Service d'Oncologie Médicale - Hôpital des Diaconesses
Paris, 75012, France
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Service d'Oncologie Médicale - ICO Centre René Gauducheau
Saint-Herblain, 44805, France
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Service d'Oncologie Médicale - ICO Paul Papin
Angers, 49100, France
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Service d'Oncologie Médicale - Institut Bergonié
Bordeaux, 33076, France
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Service d'Oncologie Médicale - Institut Claudius Regaud
Toulouse, 31300, France
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Service d'Oncologie Médicale - Institut Paoli Calmettes
Marseille, 13273, France
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Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle
Montpellier, 34298, France
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Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
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Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
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Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire
Saint-Grégoire, 35760, France
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Service d'Oncologie Radiothérapie - Clinique de Valdegour
Nîmes, 30900, France
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Service d'Oncologie Service 2 B Nord - Centre Léon Bérard
Lyon, 69373, France
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Service d'Oncologie multidisciplinaire - Hôpital Nord
Marseille, 13915, France
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Service d'Uro-Gynécologie - Centre François Baclesse
Caen, 14076, France
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Service de Chimiothérapie - Centre Catherine de Sienne
Nantes, 44202, France
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Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman
Thonon-les-Bains, 74203, France
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Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap
Gap, 05000, France
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Service de Médecine Interne et Oncologie Médicale - CH du Mans
Le Mans, 72000, France
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Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy
Villejuif, 94800, France
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Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin
Saint-Mandé, 94163, France
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Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan
Brest, 29200, France
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Service de cancérologie clinique - Institut Sainte-Catherine
Avignon, 84918, France
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Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495, France
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Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy
Pringy, 74374, France
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Servide d'Oncologie Médicale - Centre Jean Perrin
Clermont-Ferrand, 63000, France
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Servide d'Oncologie Médicale - Hôpital Jean Minjoz
Besançon, 25030, France
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Servide d'Oncologie Médicale - Institut Jean Godinot
Reims, 51056, France
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Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille
Quimper, 29107, France
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Ulls13 - Mirano
Mirano, Italy
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service d'Oncologie Médicale - Centre Hospitalier Broussais
St-Malo, 35403, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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