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Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Sponsor: University Hospital, Toulouse
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.
Official title: Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2020-07-17
Completion Date
2026-12
Last Updated
2023-09-21
Healthy Volunteers
No
Interventions
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
Locations (11)
CHU de Bordeaux
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
CHI Créteil
Créteil, France
Institut Paoli Calmettes
Marseille, France
CH Lyon Sud
Pierre-Bénite, France
CHU de Poitiers
Poitiers, France
Institut de Cancérologie de l'Ouest - Nantes
Saint-Herblain, France
CHU La Réunion
Saint-Pierre, France
Clinique Pasteur
Toulouse, France
University Hospital Toulouse
Toulouse, France
CHU de Tours
Tours, France