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Ovarian Cancer Stage IVCHRONONCT03579394

Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

A study testing Retarded IDS (Interval Debulking Surgery) and Standard IDS (Interval Debulking Surgery) in people with Ovarian Cancer Stage IV and Ovarian Cancer Stage IIIC, run by ARCAGY/ GINECO GROUP at 28 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
What is being tested?
Retarded IDS (Interval Debulking Surgery) and Standard IDS (Interval Debulking Surgery)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
28 sitesFrance
Study dates
19 Oct 2018to 17 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • ICA - Polyclinique Urbain V

    Avignon, 84000

  • Institut Bergonié

    Bordeau, 33076

  • CHU de BREST - Hôpital Cavale Blanche

    Brest, 29200

  • Centre François Baclesse

    Caen, 14000

  • Centre Hospitalier Universitaire Caen

    Caen, 14033

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Hôpital Simone Veil

    Eaubonne, 95602

  • CHU Grenoble-Alpes - Site Nord (La Tronche)

    Grenoble, 38043

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000

  • CHU de Limoges - Hôpital de la Mère et de l'Enfant

    Limoges, 87000

  • Hôpital du Scorff

    Lorient, 56100

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital Saint-Joseph

    Marseille, 13008

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Hôpital Privé du Confluent

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Groupe Hospitalier Pitié Salpétrière

    Paris, 75651

  • Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Hôpital René Huguenin, Institut Curie

    Saint-Cloud, 92210

  • ICO Centre René Gauducheau

    Saint-Herblain, 44805

  • Clinique Médico-chirurgicale CHARCOT

    Sainte-Foy-lès-Lyon, 69110

  • Institut Claudius Regaud

    Toulouse, 31059

  • Centre Hospitalier Universitaire Bretonneau

    Tours, 37000

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: 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.

Being tested
Retarded IDS (Interval Debulking Surgery), Standard IDS (Interval Debulking Surgery)
Keywords
ovarian cancer, retarded surgery, neoadjuvant chemotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retarded IDS (Interval Debulking Surgery)Procedure or 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)Procedure or 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)
Study groups in NCT03579394
Study groupRoleWhat they receive
Interval Debulking Surgery (IDS)Active comparatorComplete surgery after 3 courses of neoadjuvant chemotherapy (NACT)
Receives: Procedure: Standard IDS (Interval Debulking Surgery)
Retarded Interval Debulking Surgery (IDS)ExperimentalComplete surgery after 6 courses of neoadjuvant chemotherapy (NACT)
Receives: Procedure: Retarded IDS (Interval Debulking Surgery)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years

Secondary outcomes (9)

  1. EORTC QLQ-C30

    Health related quality of life of the patient

    Measured: through study completion, up to 2 years

  2. Pathological complete response (PCR)

    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.

    Measured: through study completion, up to 2 years

  3. Overall survival (OS)

    Overall survival (OS) defined as time interval between randomization and death (all causes); alive patients will be censored at the last date of news

    Measured: from date of randomisation to death, assessed up to 5 years

  4. Time for first subsequent treatment (TFST)

    Measured: up to 5 years

  5. Post-operative mortality

    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

    Measured: up to 5 months

  6. Post-operative morbidity

    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)

    Measured: up to 5 months

  7. Fagotti laparoscopic score

    Disease extension assessed by Fagotti score at the time of diagnosis https://www.ncbi.nlm.nih.gov/pubmed/16791447

    Measured: diagnosis

  8. CTC-AE version 4.03 adverse events

    safety assessment

    Measured: 30 days after last treatment intake, up to 1 year

  9. questionnaire OV28

    Physical, abdominal/gastrointestinal (GI), fatigue

    Measured: through study completion, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start19 Oct 2018
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579394
Sponsor's protocol ID
GINECO-CHIR101
Acronym
CHRONO
Status last verified
Feb 2026
First submitted
31 May 2018
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35321888

Questions about this trial

What is this clinical trial studying?

A study testing Retarded IDS (Interval Debulking Surgery) and Standard IDS (Interval Debulking Surgery) in people with Ovarian Cancer Stage IV and Ovarian Cancer Stage IIIC, run by ARCAGY/ GINECO GROUP at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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