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

Study acronym: ONCOCOL01
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 21, 2023 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Sep 2024 to Sep 2026 Study sites: 1 to 11 · Completion date: Dec 2024 to Dec 2026 · Start date: Jul 1, 2020 to Jul 17, 2020 · 2 morev4 Show 5 more changesShow less
    • Study sites: 1 to 11
    • Completion date: Dec 2024 to Dec 2026
    • Start date: Jul 1, 2020 to Jul 17, 2020
    • Study description revised
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2019 to Jul 1, 2020 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2019 to Jul 1, 2020
    • Study sites: 0 to 1
  3. Start date: Sep 2018 to Sep 2019 Secondary endpoints revised (4)v2 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov