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Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

Study acronym: NORPPA-1
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
    • Site details revised at 1 of 13 sites
  2. Study sites revised (13)
    • Collaborators: 13 to 14
    v6
  3. Site details revised at 3 of 13 sitesv5
  4. Site details revised at 2 of 13 sitesv4
  5. Start date changed from estimate of May 1, 2024 to May 16, 2024
    • Site details revised at 1 of 13 sites
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 13 of 13 sites
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are * if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere * what is the organ preservation rate * what is the local regrowth rate
Trial Details
NCT Number NCT06328361
Lead Sponsor Tampere University Hospital
Collaborators: Tampere University, Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, North Karelia Central Hospital, Tartu University Hospital, East Tallinn Central Hospital, West Tallinn Central Hospital, North Estonia Medical Centre, Vaasa Central Hospital, Vaasa, Finland
Conditions
(from sponsor)		 Rectal Cancer, Rectal Adenocarcinoma
Related terms Rectal Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov