Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
CHRONO
CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
1 other identifier
interventional
211
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedStudy Start
First participant enrolled
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2025
CompletedFebruary 10, 2026
February 1, 2026
7 years
May 31, 2018
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Free Survival
Disease free survival (DFS) defined as the time interval between randomization and physical or radiographic evidence of recurrence (local/distant) or second cancer or death (all causes) whichever occur first
From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years
Secondary Outcomes (9)
EORTC QLQ-C30
through study completion, up to 2 years
Pathological complete response (PCR)
through study completion, up to 2 years
Overall survival (OS)
from date of randomisation to death, assessed up to 5 years
Time for first subsequent treatment (TFST)
up to 5 years
Post-operative mortality
up to 5 months
- +4 more secondary outcomes
Study Arms (2)
Interval Debulking Surgery (IDS)
ACTIVE COMPARATORComplete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
Retarded Interval Debulking Surgery (IDS)
EXPERIMENTALComplete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
- 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.
- 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).
- Pregnant or breastfeeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
ICA - Polyclinique Urbain V
Avignon, 84000, France
Institut Bergonié
Bordeau, 33076, France
CHU de BREST - Hôpital Cavale Blanche
Brest, 29200, France
Centre François Baclesse
Caen, 14000, France
Centre Hospitalier Universitaire Caen
Caen, 14033, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Georges François Leclerc
Dijon, 21079, France
Hôpital Simone Veil
Eaubonne, 95602, France
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, 38043, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000, France
CHU de Limoges - Hôpital de la Mère et de l'Enfant
Limoges, 87000, France
Hôpital du Scorff
Lorient, 56100, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital Saint-Joseph
Marseille, 13008, France
ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital Privé du Confluent
Nantes, 44202, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Cochin
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Groupe Hospitalier Pitié Salpétrière
Paris, 75651, France
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Institut Jean Godinot
Reims, 51056, France
Hôpital René Huguenin, Institut Curie
Saint-Cloud, 92210, France
ICO Centre René Gauducheau
Saint-Herblain, 44805, France
Clinique Médico-chirurgicale CHARCOT
Sainte-Foy-lès-Lyon, 69110, France
Institut Claudius Regaud
Toulouse, 31059, France
Centre Hospitalier Universitaire Bretonneau
Tours, 37000, France
Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
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.
PMID: 35321888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc Classe, MD, PhD
Institut de Cancérologie de l'Ouest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2018
First Posted
July 6, 2018
Study Start
October 19, 2018
Primary Completion
October 17, 2025
Study Completion
October 17, 2025
Last Updated
February 10, 2026
Record last verified: 2026-02