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Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

NCT03579394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Ovarian Cancer Stage IV
  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IIIb

Interventions

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)

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)

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Jean-Marc Classe, MD, PhD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-19
Primary Completion
2025-10-17
Completion
2025-10-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579394 on ClinicalTrials.gov