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This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic management | Experimental | Tumor Debulking Surgery by laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Debulking Surgery by laparoscopy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of conversion to laparotomy | Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy. | surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Port site metastases | during 1 year post surgery | |
| Morbidity: intraoperative and postoperative complications | during surgery and 1 year post surgery | |
| Pain |
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Inclusion Criteria:
No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe POMEL, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de l'Ouest, site Paul Papin | Angers | 49100 | France | |||
| CHU Estaing |
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| during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery |
| Quality of life using EORTC QLQ-C30 | before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery |
| Economic evaluation | economic evaluation will be assess by a quantification of the additional costs of surgery, duration and cost of hospitalization, number of possible re-interventions or hospitalizations. | 1 year post-surgery |
| Clermont-Ferrand |
| 63003 |
| France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Institut Curie | Paris | 75005 | France |
| Hôpital Européen Georges-Pompidou | Paris | 75015 | France |
| Institut Curie - Hôpital René Huguenin | Saint-Cloud | 92210 | France |
| Institut de Cancérologie de L'Ouest | Saint-Herblain | 44805 | France |
| Hôpital de Hautepierre | Strasbourg | 67000 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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