Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

StatusTerminated
PhasePhase 3
Started

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Record History

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  1. Trial terminated Sponsor's reason: poor accrual Show 6 more changesShow less
    • Final enrollment: 215 participants (planned 550)
    • Primary completion date changed from estimate of Aug 2030 to Jul 31, 2026
    • Interventions: Capecitabine (adjuvant) (Drug), XELOX (adjuvant) (Drug), XELOX (neoadjuvant) (Drug), infusional 5-FU/FA "AIO" regimen (adjuvant) (Drug)… to Capecitabine (adjuvant) (Drug), XELOX (adjuvant) (Drug), XELOX (neoadjuvant) (Drug), infusional 5-FU/FA "AIO" regimen (adjuvant) (Drug)…
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 6 of 13 entries
    • Site details revised
  2. Enrollment target: 818 to 550
    • Eligibility criteria expanded, about 20 words
    v7
  3. 3 versions Re-verified since Nov 4, 2021, no change to tracked fieldsv4-v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Sep 30, 2020
    • Site details revised
    v3
  5. Secondary endpoints: details revised at 3 of 13 entriesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure
Trial Details
NCT Number NCT04495088
Lead Sponsor Ralf Hofheinz
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany), Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, German Rectal Cancer Study Group
Conditions
(from sponsor)		 Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 215 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov