Clinical Trial

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

Study acronym: ONCOCOL01
Recruiting Phase 3
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2018-05-22; most recent amendment 2023-09-18.
Status change: Not Yet Recruiting → Recruiting 2020-07-29
Trial Details
NCT Number NCT03534713
Lead Sponsor University Hospital, Toulouse
Collaborators: Institut Claudius Regaud
Conditions Cervical Cancer TNM Staging Regional Lymph Nodes (N)
Enrollment 310 participants
Start Date 2020-07-17
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2023-09-21