Trials / Completed
CompletedNCT03579394
Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- ARCAGY/ GINECO GROUP · Academic / Other
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2018-10-19
- Primary completion
- 2025-10-17
- Completion
- 2025-10-17
- First posted
- 2018-07-06
- Last updated
- 2026-02-10
Locations
28 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03579394. Inclusion in this directory is not an endorsement.