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Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET

Study acronym: ReLUTH
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion pushed from Oct 2031 to Oct 2033
    • Study sites revised (28)
    v13
  2. Publications: details revised at 1 of 12 entriesv12
  3. Re-verified, no change to tracked fieldsv11
  4. Site contacts updated at 2 of 28 sitesv10
  5. Primary completion date: Mar 2025 to Oct 2031
    • Study completion date: Sep 2029 to Oct 2031
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 24 to 28v8
  2. Study sites: 22 to 24
    • Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Study title shortened, about 3 words
    v7
  3. Site details revised at 2 of 22 sitesv6
  4. Study sites: 18 to 22
    • Study title shortened, about 1 word
    v5
  5. Site details revised at 9 of 18 sites
    • Eligibility criteria expanded, about 1 word
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Oct 18, 2021
    • Site details revised at 18 of 18 sites
    v3
  7. Publications: details revised at 11 of 12 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.
Trial Details
NCT Number NCT04954820
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)		 Neuroendocrine Tumors, Intestinal Well Differentiated Endocrine Tumor, Progressive Disease
Related terms Disease Progression, Neuroendocrine Tumors
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov