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Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma

Study acronym: TRESOR
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study sites: 1 to 11v4
  2. Minor Eligibility criteria expanded, about 63 words
    • Site contact updated
    v3
  3. Minor Eligibility criteria shortened, about 29 wordsv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.1 to 6 cm, cT2N1 or T3N0-1, M0).
Trial Details
NCT Number NCT06402864
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)
Adult With Intermediate Low or Mid Rectal Adenocarcinoma
Enrollment 212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov