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Induction Chemotherapy for Locally Recurrent Rectal Cancer

Study acronym: PelvEx II
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 6, 2022 (before its estimated March 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 9 to 14
    • Eligibility criteria shortened, about 24 words
    v4
  2. Site details revised at 6 of 9 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 9
    • Start date changed from estimate of Sep 1, 2020 to Nov 13, 2020
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
Trial Details
NCT Number NCT04389086
Lead Sponsor Catharina Ziekenhuis Eindhoven
Conditions
(from sponsor)		 Recurrent Rectal Cancer
Related terms Margins of Excision, Rectal Neoplasms
Enrollment 364 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov