NCT03534713 Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
| NCT ID | NCT03534713 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Toulouse |
| Condition | Cervical Cancer TNM Staging Regional Lymph Nodes (N) |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2020-07-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 310 participants in total. It began in 2020-07-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Stéphanie MOTTON, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT03534713 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer TNM Staging Regional Lymph Nodes (N). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03534713 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 310 participants.
Is NCT03534713 currently recruiting?
Yes, NCT03534713 is actively recruiting participants. Contact the research team at motton.stephanie@iuct-oncopole.fr for enrollment information.
Where is the NCT03534713 trial being conducted?
This trial is being conducted at Bordeaux, France, Clermont-Ferrand, France, Créteil, France, Marseille, France and 7 additional locations.
Who is sponsoring the NCT03534713 clinical trial?
NCT03534713 is sponsored by University Hospital, Toulouse. The principal investigator is Stéphanie MOTTON, MD at University Hospital, Toulouse. The trial plans to enroll 310 participants.
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