Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer (CHRONO)

February 6, 2026 updated by: ARCAGY/ GINECO GROUP

CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • ICA - Polyclinique Urbain V
      • Bordeau, France, 33076
        • Institut Bergonie
      • Brest, France, 29200
        • CHU de BREST - Hôpital Cavale Blanche
      • Caen, France, 14000
        • Centre François Baclesse
      • Caen, France, 14033
        • Centre Hospitalier Universitaire Caen
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Eaubonne, France, 95602
        • Hôpital Simone Veil
      • Grenoble, France, 38043
        • CHU Grenoble-Alpes - Site Nord (La Tronche)
      • Le Mans, France, 72000
        • Centre Jean Bernard - Clinique Victor Hugo
      • Limoges, France, 87000
        • CHU de Limoges - Hôpital de la Mère et de l'Enfant
      • Lorient, France, 56100
        • Hôpital du Scorff
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13008
        • Hôpital Saint-Joseph
      • Montpellier, France, 34298
        • ICM Val d'Aurelle
      • Nantes, France, 44202
        • Hôpital Privé du Confluent
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75651
        • Groupe Hospitalier Pitié Salpêtrière
      • Poitiers, France, 86021
        • Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers
      • Reims, France, 51056
        • Institut Jean Godinot
      • Saint-Cloud, France, 92210
        • HOPITAL RENE HUGUENIN, Institut Curie
      • Saint-Herblain, France, 44805
        • ICO Centre René Gauducheau
      • Sainte-Foy-lès-Lyon, France, 69110
        • Clinique Médico-chirurgicale CHARCOT
      • Toulouse, France, 31059
        • Institut Claudius Regaud
      • Tours, France, 37000
        • Centre Hospitalier Universitaire Bretonneau
      • Villejuif, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients ≥18 years.
  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:

  1. Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interval Debulking Surgery (IDS)
Complete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
Procedure: 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)
Experimental: Retarded Interval Debulking Surgery (IDS)
Complete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C30
Time Frame: through study completion, up to 2 years
Health related quality of life of the patient
through study completion, up to 2 years
Pathological complete response (PCR)
Time Frame: through study completion, up to 2 years
Pathological response will be established using the grading system called chemotherapy response score (CRS). The response will be assessed based on the omentum microscopic review.
through study completion, up to 2 years
Overall survival (OS)
Time Frame: from date of randomisation to death, assessed up to 5 years
Overall survival (OS) defined as time interval between randomization and death (all causes); alive patients will be censored at the last date of news
from date of randomisation to death, assessed up to 5 years
Time for first subsequent treatment (TFST)
Time Frame: up to 5 years
up to 5 years
Post-operative mortality
Time Frame: up to 5 months
Post operative mortality defined as the interval between the date of debulking surgery and the date of death due to any cause occurring within the 30 day post-surgery
up to 5 months
Post-operative morbidity
Time Frame: up to 5 months
Surgical morbidity defined as the interval between the date of debulking surgery and any events occurring within the 30 day post-surgery (All grades ≥ 3 according to the CTCAE v4.03 & All grades ≥ 3 according to Clavien Dindo classification)
up to 5 months
Fagotti laparoscopic score
Time Frame: diagnosis
Disease extension assessed by Fagotti score at the time of diagnosis https://www.ncbi.nlm.nih.gov/pubmed/16791447
diagnosis
CTC-AE version 4.03 adverse events
Time Frame: 30 days after last treatment intake, up to 1 year
safety assessment
30 days after last treatment intake, up to 1 year
questionnaire OV28
Time Frame: through study completion, up to 2 years
Physical, abdominal/gastrointestinal (GI), fatigue
through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Jean-Marc Classe, MD, PhD, Institut de cancérologie de l'Ouest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

October 17, 2025

Study Completion (Actual)

October 17, 2025

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-CHIR101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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