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Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients

Study acronym: WW3
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Phase: Phase 2 to Phase 3v11 Show 4 more changesShow less
    • Enrollment target: 111 to 162
    • Primary completion date: Dec 2027 to Dec 2026
    • Study completion date: Dec 2028 to Dec 2033
    • Site details revised at 2 of 5 sites
  2. 5 versions Re-verified since May 19, 2021, no change to tracked fieldsv6-v10
  3. Site details revised at 1 of 5 sitesv5
  4. Start date changed from estimate of Jan 2020 to Jan 20, 2020v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2019 to Jan 2020
    • Site details revised at 5 of 5 sites
    v3
  6. Secondary endpoints revised (7)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level. The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.
Trial Details
NCT Number NCT04095299
Lead Sponsor Vejle Hospital
Conditions
(from sponsor)		 Cancer of Rectum
Related terms Rectal Neoplasms
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov