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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
211
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)
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)
ICA - Polyclinique Urbain V
Avignon, France
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
Time frame: From date of randomisation until the date of second cancer or death, which ever occurs earlier, assessed up to 5 years
EORTC QLQ-C30
Health related quality of life of the patient
Time frame: through study completion, up to 2 years
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.
Time frame: through study completion, up to 2 years
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
Time frame: from date of randomisation to death, assessed up to 5 years
Time for first subsequent treatment (TFST)
Time frame: up to 5 years
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
Time frame: up to 5 months
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)
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Institut Bergonié
Bordeau, France
CHU de BREST - Hôpital Cavale Blanche
Brest, France
Centre François Baclesse
Caen, France
Centre Hospitalier Universitaire Caen
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges François Leclerc
Dijon, France
Hôpital Simone Veil
Eaubonne, France
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, France
...and 18 more locations
Time frame: up to 5 months
Fagotti laparoscopic score
Disease extension assessed by Fagotti score at the time of diagnosis https://www.ncbi.nlm.nih.gov/pubmed/16791447
Time frame: diagnosis
CTC-AE version 4.03 adverse events
safety assessment
Time frame: 30 days after last treatment intake, up to 1 year
questionnaire OV28
Physical, abdominal/gastrointestinal (GI), fatigue
Time frame: through study completion, up to 2 years