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Completed

NCT Number: NCT03579394

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Retarded IDS (Interval Debulking Surgery)

Procedure

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

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. EORTC QLQ-C30

    Time frame: through study completion, up to 2 years

    Health related quality of life of the patient

  2. 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.

  3. 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

  4. Time for first subsequent treatment (TFST)

    Time frame: up to 5 years

  5. 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

  6. 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)

  7. 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

  8. CTC-AE version 4.03 adverse events

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

    safety assessment

  9. questionnaire OV28

    Time frame: through study completion, up to 2 years

    Physical, abdominal/gastrointestinal (GI), fatigue

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

Acronym: CHRONO

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2018
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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