NCT03579394Completed
Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
The aim of CHRONO trial is to compare the DFS when surgery is performed after 3 courses of NACT, or after 6 courses of NACT, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 31 May 2018
- Start date
- 19 Oct 2018
- Primary completion date
- 17 Oct 2025
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Diseases
- Ovarian cancer
- NCT number
- NCT03579394
What you commit to
- Study type: Interventional
- Participants enrolled: 211
- From 19 Oct 2018 to the primary completion date, 17 Oct 2025
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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).
- 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.
Other
- Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
- Pregnant or breastfeeding women.
Who the study is looking for
- Female patients ≥18 years.
- 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.
- Performance status \< 2 (see Appendix 2).
- 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 \[not mandatory for stage IVA\]).
- Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy
- 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.
- Signed informed consent obtained prior to any study-specific procedures.
- Patient affiliated to, or a beneficiary of, a social security category
Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICA - Polyclinique Urbain V Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeau | France | Unknown status |
| Chu de Brest - Hôpital Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Centre Hospitalier Universitaire Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Simone Veil Coordinator of this site? Confirm its status | Eaubonne | France | Unknown status |
| CHU Grenoble-Alpes - Site Nord (La Tronche) Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Jean Bernard - Clinique Victor Hugo Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| CHU de Limoges - Hôpital de la Mère et de l'Enfant Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hôpital du Scorff Coordinator of this site? Confirm its status | Lorient | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| ICM Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Groupe Hospitalier Pitie - Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Institut Jean Godinot Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| HOPITAL RENE HUGUENIN- Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Unknown status |
| Clinique Médico-chirurgicale CHARCOT Coordinator of this site? Confirm its status | Sainte-Foy-lès-Lyon | France | Unknown status |
| ICO - Centre René Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Centre Hospitalier Universitaire Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.