Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 31, 2026 → Dec 31, 2026
See other at-risk trials from Radiation Therapy Oncology Group

Record History

The 50 most recent of 130 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 31, 2026 to Dec 31, 2026 Show 4 more changesShow less
    • Study completion pushed from Oct 2028 to Dec 31, 2031
    • Eligibility criteria expanded, about 39 words
    • Study description expanded, about 10 words
    • Site details revised at 22 of 268 sites
  2. Re-verified, no change to tracked fieldsv129
  3. Site details revised at 1 of 268 sitesv128
  4. Primary completion date: Oct 2023 to Oct 31, 2026v127
  5. Re-verified, no change to tracked fieldsv126
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 233 to 268v125
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 252
    • Site details revised at 233 of 233 sites
    v124
  3. Study sites: 95 to 233v123
  4. Re-verified, no change to tracked fieldsv122
  5. Study sites: 94 to 95
    • Study completion date: Oct 2028
    v121
  6. Study description expanded, about 57 words
    • Eligibility criteria expanded, about 5 words
    v120
  7. Primary completion date: Aug 2016 to Oct 2023v119
  8. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 94 of 94 sites
    v118
  9. Re-verified, no change to tracked fieldsv117
  10. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 94 of 94 sites
    v116
  11. Study Status, Sponsor/Collaboratorsv115
  12. Re-verified, no change to tracked fieldsv114
  13. Eligibility criteria expanded, about 12 words
    • Site contacts updated at 7 of 94 sites
    v113
  14. Study sites revised (94)v112
  15. Study sites: 93 to 94v111
  16. Study sites: 92 to 93v110
  17. Study sites: 91 to 92v109
  18. Study sites: 90 to 91v108
  19. Study sites revised (90)v107
  20. Study sites: 89 to 90v106
  21. Study sites: 88 to 89v105
  22. Study sites: 89 to 88v104
  23. Study sites: 88 to 89v103
  24. Study sites: 87 to 88v102
  25. Primary completion date: Jan 2014 to Aug 2016v101
  26. Study sites: 86 to 87v100
  27. Study sites: 85 to 86v99
  28. Study sites: 83 to 85v98
  29. Study sites: 82 to 83v97
  30. Study sites: 81 to 82v96
  31. Study sites: 78 to 81v95
  32. Site contacts updated at 1 of 78 sitesv94
  33. Study sites: 71 to 78v93
  34. Study sites: 66 to 71v92
  35. Study sites: 70 to 66v91
  36. Study sites: 71 to 70v90
  37. Study sites: 70 to 71v89
  38. Study sites: 69 to 70v88
  39. Study sites: 66 to 69v87
  40. Study sites: 65 to 66v86
  41. Study sites: 63 to 65v85
  42. Study sites: 64 to 63v84
  43. Study sites: 59 to 64v83
  44. Study sites: 57 to 59v82
  45. Study sites: 69 to 57v81
  • 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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
Trial Details
NCT Number NCT01220583
Lead Sponsor Radiation Therapy Oncology Group
Collaborators: National Cancer Institute (NCI), NRG Oncology
Conditions
(from sponsor)		 Head and Neck Cancer
Related terms Head and Neck Neoplasms, Salivary Gland Neoplasms
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov