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| Name | Class |
|---|---|
| GERCOR - Multidisciplinary Oncology Cooperative Group | OTHER |
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CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
This is a randomized phase II study, open-label and multicentric. After initial intervention (debulking surgery or diagnostic surgery) patient will randomized in the study according to Completeness of cytoreduction (CC) score (CC0 or CC>1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel. The regimen of administration of the chemotherapy is as following:
one cycle every 3 weeks |
|
| Experimental arm | Experimental | Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin.
The regimen of administration of the chemotherapy is as following:
one Cycle every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC0 - Carboplatin (IV) - Paclitaxel (IV) | Drug | (6 cycles) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete peritoneal response (pCR) | Interval debulking surgery or final evaluation peritoneal surgery | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QLQ -C30) assessment | Up to 2-year (at inclusion, after 3 cycles and end of treatment) | |
| Quality of life (QLQ-OV28) assessment | Up to 2-year (at inclusion, after 3 cycles and end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard VILLET, MD | Contact | 33 (0) 1 44 74 10 42 | ||
| Delphine COCHEREAU, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Richard VILLET, MD | Groupe Hospitalier Diaconessess Croix Saint Simon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Recruiting | Dijon | France |
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| CC0 - Cisplatin (IP) - Epirubicin (IV) |
| Drug |
(6 cycles) |
|
| CC>0 - Carboplatin (IV)- Paclitaxel (IV) | Drug |
|
|
| CC>0 - Cisplatin (IP/IV)- Epirubicin (IV) | Drug |
|
|
| IPSS score | Up to 2-year (at inclusion, after 3 cycles and end of treatment) |
| Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03 | 2-year |
| Event-free survival (EFS) | At 5-year and 10-year |
| Objective response rate at the various surgical step | Up to 2-year |
| Overall survival (OS) | At 5-year and 10-year |
| Institut Hospitalier Franco-Britannique | Recruiting | Levallois-Perret | France |
|
| Groupe Hospitalier Diaconesses Croix Saint Simon | Recruiting | Paris | France |
|
| Hôpital Saint Antoine | Recruiting | Paris | France |
|
| Hôpital Poissy Saint Germain | Recruiting | Poissy | France |
|
| CHU Poitiers | Recruiting | Poitiers | France |
|
| Centre Hospitalier Senlis | Recruiting | Senlis | France |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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