Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Record History

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  1. Trial status changed: Suspended → Active, Not Recruiting Show 6 more changesShow less
    • Final enrollment: 475 participants (planned 1714)
    • Study completion pushed from Feb 9, 2027 to Feb 9, 2032
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Study description revised
    • Site details revised at 16 of 370 sites
  2. Study sites revised (370)v25
  3. 2 versions Re-verified since Apr 2, 2026, no change to tracked fieldsv23-v24
  4. Primary and study completion dates: Feb 9, 2026 to Feb 9, 2027v22
  5. Study sites revised (370)v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 368 to 370v20
  2. Trial status: Recruiting to Suspended Sponsor's reason: End of Initial Phase of Multi-phase protocol; closed for protocol specified analysis
    • Site details revised at 368 of 368 sites
    v19
  3. Study sites: 366 to 368v18
  4. Study sites: 363 to 366v17
  5. Study sites: 358 to 363v16
  6. Enrollment target: 464 to 1714v15 Show 10 more changesShow less
    • Primary and study completion dates moved earlier to Feb 9, 2026
    • Start date: Oct 27, 2021 to Feb 1, 2022
    • Study sites: 352 to 358
    • Interventions: Cisplatin (Drug), Cisplatin (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other), Radiation Therapy (Radiation) to Cisplatin (Drug), Cisplatin (Drug), Computed Tomography (Procedure), Magnetic Resonance Imaging (Procedure), Positron Emission Tomography…
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 11
    • Primary endpoints revised (3)
    • Study description shortened, about 85 words
    • Study arms: 4 to 2
    • Study title shortened, about 2 words
  7. Study sites revised (352)v14
  8. Study sites: 312 to 352v13
  9. Study sites: 275 to 312v12
  10. Study sites: 271 to 275v11
  11. Study sites: 266 to 271v10
  12. Study sites: 245 to 266v9
  13. Study sites: 223 to 245v8
  14. Eligibility criteria expanded, about 79 wordsv7
  15. Study sites: 199 to 223v6
  16. Study sites: 135 to 199v5
  17. Study sites: 46 to 135v4
  18. Study sites: 1 to 46v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 9, 2022 to Oct 27, 2021
    v2
  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.
NRG Oncology
67 trials monitored
See 5 trials at risk
Head & Neck Cancer
2,621 trials monitored
See 150 trials at risk
This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence.
Trial Details
NCT Number NCT05050162
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 +2 more
Related terms Carcinoma, Oropharyngeal Neoplasms
Enrollment 475 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov