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Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

StatusRecruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 679 sitesv29
  2. Trial sites expanded: 676 → 679 locationsv28
  3. Re-verified, no change to tracked fieldsv27
  4. Site details revised at 1 of 676 sitesv26
  5. Trial sites expanded: 640 → 676 locationsv25
Show 23 earlier versionsHide 23 earlier versions
  1. 8 versions Re-verified since Sep 15, 2025, no change to tracked fieldsv17-v24
  2. Site details revised at 1 of 640 sitesv16
  3. Study sites: 579 to 640v15
  4. Re-verified, no change to tracked fieldsv14
  5. Start date: Mar 29, 2016 to Nov 23, 2016v13
  6. Primary completion date: Jan 1, 2026 to Dec 31, 2027
    • Study completion date: May 1, 2027 to Dec 31, 2027
    v12
  7. Primary completion date: May 1, 2022 to Jan 1, 2026v11
  8. Site details revised at 20 of 579 sitesv10
  9. Study sites: 508 to 579v9
  10. Study sites: 500 to 508v8
  11. Enrollment target: 345 to 189v7
  12. Study sites: 460 to 500v6
  13. Primary endpoint revisedv5 Show 7 more changesShow less
    • Study sites: 245 to 460
    • Primary completion date: May 2022 to May 1, 2022
    • Study completion date: May 2027 to May 1, 2027
    • Start date: Mar 2016 to Mar 29, 2016
    • Eligibility criteria expanded, about 177 words
    • Secondary endpoints revised (4)
    • Study title revised
  14. Primary completion date: Dec 2021 to May 2022
    • Study completion date: Dec 31, 2022 to May 2027
    v4
  15. Study completion date: Dec 31, 2022v3
  16. Study sites: 1 to 245v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.
Trial Details
NCT Number NCT02734537
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma, p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8 +8 more
Related terms Carcinoma, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Lymphoid Interstitial Pneumonia, Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 189 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov