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Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma

Study acronym: GRECCAR14
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Aug 2026 → Sep 2029
See other at-risk trials from Institut du Cancer de Montpellier - Val d'Aurelle

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Sep 2029
    • Study completion pushed from Aug 2026 to Sep 2031
    v21
  2. Publications: 12 to 13v20
  3. Study sites: 29 to 30
    • Primary and study completion dates: Aug 2027 to Aug 2026
    v19
  4. Study sites: 27 to 29v18
  5. Re-verified, no change to tracked fieldsv17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites revised (27)v16
  2. Site details revised at 7 of 27 sitesv15
  3. Study sites: 26 to 27
    • Eligibility criteria shortened, about 6 words
    v14
  4. Enrollment target: 430 to 1075v13
  5. Study sites: 19 to 26
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints revised (25)
    v12
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 20 to 19
    • Start date changed from estimate of Nov 2021 to Nov 26, 2021
    v11
  7. Start date: Sep 2021 to Nov 2021v10
  8. Study sites: 19 to 20
    • Secondary endpoints: 22 to 25
    v9
  9. Eligibility criteria revised
    • Secondary endpoints: 21 to 22
    v8
  10. Study sites: 23 to 19v7
  11. Eligibility criteria shortened, about 7 wordsv6
  12. Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 18 to 21
    v5
  13. Primary endpoints revised (2)v4 Show 4 more changesShow less
    • Study sites: 28 to 23
    • Interventions: Early tumor response evaluation by MRI volumetry (Other), Induction chemotherapy - FOLFIRINOX regimen (Drug), Radical proctectomy with… to Early tumor response evaluation by MRI volumetry (Other), Induction chemotherapy - modified FOLFIRINOX regimen (Drug), Radical proctectomy…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 22 to 18
  14. Study sites: 0 to 28
    • Secondary endpoints: details revised at 1 of 22 entries
    v3
  15. Secondary endpoints: 12 to 22v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
Trial Details
NCT Number NCT04749108
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)		 Locally Advanced Malignant Neoplasm, Rectal Carcinoma
Related terms Rectal Neoplasms
Enrollment 1,075 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov