Neoadjuvant chemotherapy followed by standard treatment for cervical cancer with lymph node spread
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.
Run by University Hospital, Toulouse · NCT03534713 · Data updated 2026-11-12
This study is testing if giving chemotherapy before standard treatment helps women with cervical cancer that has spread to lymph nodes live longer and have a better quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 310 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (Bordeaux and 10 other locations) |
| Status | Recruiting |
| Started | July 17, 2020 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | September 21, 2023 |
| Trial ID | NCT03534713 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with histologically confirmed invasive cervical carcinoma and paraaortic lymphadenopathy.
✕Probably not a fit
Patients with cervical cancer that does not involve paraaortic lymph nodes or those with severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of neoadjuvant chemotherapy using Carboplatin and Paclitaxel followed by standard cisplatin-based chemoradiation in women with cervical cancer that has spread to the paraaortic lymph nodes. Participants will be randomly assigned to receive either the experimental treatment or standard therapy alone. The study will recruit 310 patients over 4.5 years, with a follow-up period of 3 years to assess overall survival rates and other outcomes. Secondary objectives include comparing progression-free survival, toxicity, disease recurrence patterns, and quality of life between the two groups.
Why it matters
Potential benefit: If successful, this approach could significantly improve overall survival rates for women with cervical cancer and paraaortic lymph node involvement.
How similar studies have gone: While the specific approach of neoadjuvant chemotherapy for this condition is novel, similar studies have shown promise in improving outcomes for other cancers with lymph node involvement.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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
Show 5 more locations
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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
Study contacts
- Principal investigator: Stéphanie MOTTON, MD — University Hospital, Toulouse
- Study coordinator: Stéphanie MOTTON, MD
- Email: motton.stephanie@iuct-oncopole.fr
- Phone: +335 61 32 37 08
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.