Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
NCT ID: NCT03579394
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
211 participants
INTERVENTIONAL
2018-10-19
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interval Debulking Surgery (IDS)
Complete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
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)
Retarded Interval Debulking Surgery (IDS)
Complete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception of mucinous, clear cell and carcinosarcoma histologies.
3. Performance status \< 2 (see Appendix 2).
4. Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1) stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmed by open laparoscopy or by laparotomy \[not mandatory for stage IVA\]).
5. Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy
6. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
* White blood cells (WBC) \>3x109/L, absolute neutrophil count (ANC) ≥1,5x109/L, platelets (PLT)
≥100x109/L, hemoglobin (Hb) ≥9 g/dL,
* Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥ 30 mL/min according to Cockroft-Gault formula or to local lab measurement, serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
7. Signed informed consent obtained prior to any study-specific procedures.
8. Patient affiliated to, or a beneficiary of, a social security category
Exclusion Criteria
2. Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
3. Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on this study.
4. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders).
5. Pregnant or breastfeeding women.
18 Years
99 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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Principal Investigators
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Jean-Marc Classe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de l'Ouest
Locations
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ICA - Polyclinique Urbain V
Avignon, , France
Institut Bergonié
Bordeau, , France
CHU de BREST - Hôpital Cavale Blanche
Brest, , France
Centre François Baclesse
Caen, , France
Centre Hospitalier Universitaire Caen
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
Hôpital Simone Veil
Eaubonne, , France
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, , France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, , France
CHU de Limoges - Hôpital de la Mère et de l'Enfant
Limoges, , France
Hôpital du Scorff
Lorient, , France
Centre Léon Bérard
Lyon, , France
Hôpital Saint-Joseph
Marseille, , France
ICM Val d'Aurelle
Montpellier, , France
Hôpital Privé du Confluent
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Groupe Hospitalier Pitié Salpétrière
Paris, , France
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Institut Jean Godinot
Reims, , France
Hôpital René Huguenin, Institut Curie
Saint-Cloud, , France
ICO Centre René Gauducheau
Saint-Herblain, , France
Clinique Médico-chirurgicale CHARCOT
Sainte-Foy-lès-Lyon, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau
Tours, , France
Gustave Roussy
Villejuif, , France
Countries
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References
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Classe JM, Ferron G, Ouldamer L, Gauthier T, Emambux S, Gladieff L, Dupre PF, Anota A. CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer. Int J Gynecol Cancer. 2022 Aug 1;32(8):1071-1075. doi: 10.1136/ijgc-2021-003320.
Other Identifiers
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GINECO-CHIR101
Identifier Type: -
Identifier Source: org_study_id
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