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Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

Study acronym: MORPHEUS
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 1 word
    • Study title expanded, about 3 words
    v19
  2. Primary completion date: Jan 2026 to Jan 2028
    • Study sites revised (4)
    v18
  3. Enrollment target: 145 to 131
    • Study sites: 1 to 4
    v17
  4. Primary completion date: Jan 2024 to Jan 2026
    • Study completion date: Jan 2027 to Jan 2030
    v16
  5. Site contact updatedv15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary endpoint revisedv14
  2. Secondary endpoints: details revised at 3 of 4 entries
    • Site contact updated
    v13
  3. Phase: Not applicable to Phase 2/3v12 Show 4 more changesShow less
    • Enrollment target: 40 to 145
    • Primary completion date: Jan 2021 to Jan 2024
    • Study completion date: Jan 2022 to Jan 2027
    • Study description expanded, about 18 words
  4. 3 versions Re-verified since Sep 17, 2019, no change to tracked fieldsv9-v11
  5. Secondary endpoints revised (4)v8
  6. 3 versions Re-verified since Sep 20, 2017, no change to tracked fieldsv5-v7
  7. Start date: Jan 22, 2017 to Apr 25, 2017v4
  8. Primary completion date: Jan 2019 to Jan 2021
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 4 entries
    v3
  9. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
Trial Details
NCT Number NCT03051464
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)		 Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
Related terms Rectal Neoplasms
Enrollment 131 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov