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RECRUITING
NCT03534713
PHASE3

Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

DRUG

Carboplatin

carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles

DRUG

Paclitaxel

paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles

DRUG

Cisplatin

Cisplatin 40mg/m² given once a week during 5 weeks

RADIATION

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