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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
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

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ICA - Polyclinique Urbain V
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AvignonFranceUnknown status
Institut Bergonie
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BordeauFranceUnknown status
Chu de Brest - Hôpital Cavale Blanche
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BrestFranceUnknown status
Centre Hospitalier Universitaire Caen
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CaenFranceUnknown status
Centre François Baclesse
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CaenFranceUnknown status
Centre Jean Perrin
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Clermont-FerrandFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
Hôpital Simone Veil
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EaubonneFranceUnknown status
CHU Grenoble-Alpes - Site Nord (La Tronche)
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GrenobleFranceUnknown status
Centre Jean Bernard - Clinique Victor Hugo
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Le MansFranceUnknown status
CHU de Limoges - Hôpital de la Mère et de l'Enfant
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LimogesFranceUnknown status
Hôpital du Scorff
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LorientFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Hôpital Saint Joseph
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MarseilleFranceUnknown status
ICM Val d'Aurelle
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MontpellierFranceUnknown status
Hôpital Privé du Confluent
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NantesFranceUnknown status
Centre Antoine Lacassagne
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NiceFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Groupe Hospitalier Pitie - Salpetriere
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceUnknown status
Institut Jean Godinot
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ReimsFranceUnknown status
HOPITAL RENE HUGUENIN- Institut Curie
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Saint-CloudFranceUnknown status
Clinique Médico-chirurgicale CHARCOT
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Sainte-Foy-lès-LyonFranceUnknown status
ICO - Centre René Gauducheau
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Saint-HerblainFranceUnknown status
Institut Claudius Regaud
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ToulouseFranceUnknown status
Centre Hospitalier Universitaire Bretonneau
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ToursFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.