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Recruiting Phase 3

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

NCT03534713 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2020-07-17
Last updated
2023-09-21

Condition(s) studied

Cervical Cancer TNM Staging Regional Lymph Nodes (N)

Investigational drug(s) / intervention(s)

Carboplatin →Paclitaxel →Cisplatin →Radiotherapy

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women with histologically proven invasive carcinoma of the uterine cervix and para aortic lymphadenopathy determined by either a positive positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography or if negative positron emission tomography computed tomography based on histological examination of paraaortic lymph node dissection. * Performance status Eastern Cooperative Oncology Group 0-2 * Stage International Federation of Gynecology and Obstetrics IB1 to IVA at diagnosis with para-aortic lymph node involvement * Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma * Adequate renal function (creatinine clearance ≥60 mL/min) * Adequate hepatic function (bilirubin \<1.5 times normal and Serum Glutamooxaloacetate Transferase \< 3 times normal) * Adequate hematopoietic function Platelet count \> 100x10 9/l and Absolute neutrophil count \> 1.5X10 9/l) * Written Informed consent for participation Exclusion Criteria: * Stage Federation of Gynecology and Obstetrics IVB at diagnosis * Others histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma. * Women who receive any prior chemotherapy for her cervical cancer * Pregnant or lactating women * Prior ( within the last 5 years) malignancies other than non-melanoma skin cancer * Inadequate renal, hepatic or hematopoietic function (Cf previously) * Cardiovascular pathology New York Heart Association II or more * Pre-existing Peripheral neuropathy Common toxicity Criteria grade ≥ 2

Primary outcome measure(s)

  • Overall survival — 3 years
    time between random assignment and death resulting from any cause

Trial sites (11)

FacilityCityRegionStatus
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
Official registry record

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