Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Condition(s) studied
Investigational drug(s) / intervention(s)
Carboplatin: carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
Paclitaxel: paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
Cisplatin: Cisplatin 40mg/m² given once a week during 5 weeks
Radiotherapy: 45 gray to the pelvis and para aortic area over 5 weeks + intracavitary brachytherapy alone or prior to surgery, depending on response to treatment according to the current guidelines
Study summary
The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement.
Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy.
310 patients will be recruited during 4.5 years, with 3 years of follow up period.
Eligibility
Primary outcome measure(s)
- Overall survival — 3 years
time between random assignment and death resulting from any cause
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | Recruiting |
| Centre Jean Perrin | Clermont-Ferrand | France | Recruiting |
| CHI Créteil | Créteil | France | Recruiting |
| Institut Paoli Calmettes | Marseille | France | Recruiting |
| CH Lyon Sud | Pierre-Bénite | France | Recruiting |
| CHU de Poitiers | Poitiers | France | Recruiting |
| Institut de Cancérologie de l'Ouest - Nantes | Saint-Herblain | France | Recruiting |
| CHU La Réunion | Saint-Pierre | France | Recruiting |
| Clinique Pasteur | Toulouse | France | Recruiting |
| University Hospital Toulouse | Toulouse | France | Recruiting |
| CHU de Tours | Tours | France | Recruiting |
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03534713 on ClinicalTrials.gov ↗ ← All trials in France