Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 1 month later Dec 1, 2026 → Jan 1, 2029
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from NRG Oncology

Record History

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  1. Primary completion pushed from Dec 1, 2026 to Jan 1, 2029 Show 6 more changesShow less
    • Study completion pushed from Dec 1, 2031 to Jan 1, 2034
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 11 of 13 entries
    • Study description revised
    • Site details revised at 14 of 213 sites
    • Publications: details revised at 1 of 1 entry
  2. Study completion pushed from Dec 1, 2026 to Dec 1, 2031v43
  3. Primary endpoint(s) modifiedv42 Show 10 more changesShow less
    • Start date: Apr 21, 2014 to Jul 1, 2014
    • Enrollment increased: 685 → 924 participants
    • Primary completion moved earlier from Feb 2027 to Dec 1, 2026
    • Study completion moved earlier from Feb 2032 to Dec 1, 2026
    • Interventions modified
    • Study sites: 215 to 213
    • Secondary endpoints revised (13)
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 5 words
    • Study title expanded, about 1 word
  4. Study completion pushed from Feb 2031 to Feb 2032v41
  5. Site details revised at 1 of 215 sitesv40
Show 38 earlier versionsHide 38 earlier versions
  1. Site details revised at 1 of 215 sites
    • Study title shortened, about 1 word
    v39
  2. Re-verified, no change to tracked fieldsv38
  3. Primary completion date: Feb 2026 to Feb 2027v37
  4. 2 versions Re-verified since Nov 5, 2024, no change to tracked fieldsv35-v36
  5. Enrollment target: 676 to 685v34
  6. Primary completion date: Dec 2024 to Feb 2026
    • Study completion date: Jul 2029 to Feb 2031
    v33
  7. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 758 to confirmed 676
    • Start date: Apr 2014 to Apr 21, 2014
    • Site details revised at 215 of 215 sites
    v32
  8. Study sites: 214 to 215v31
  9. Study sites: 209 to 214v30
  10. Primary completion date: Dec 2022 to Dec 2024
    • Study completion date: Jul 2026 to Jul 2029
    v29
  11. Study sites revised (209)v28
  12. Study sites: 205 to 209v27
  13. Site details revised at 36 of 205 sitesv26
  14. Eligibility criteria expanded, about 117 words
    • Site details revised at 6 of 205 sites
    v25
  15. Study sites: 200 to 205v24
  16. Primary completion date: Jul 2021 to Dec 2022v23
  17. Site details revised at 19 of 200 sitesv22
  18. Study sites: 198 to 200v21
  19. Study sites: 196 to 198v20
  20. Study sites: 193 to 196v19
  21. Study sites: 191 to 193v18
  22. Re-verified, no change to tracked fieldsv17
  23. Study sites: 190 to 191v16
  24. Study sites: 172 to 190v15
  25. Study sites: 170 to 172v14
  26. Study sites: 165 to 170v13
  27. Study sites: 157 to 165v12
  28. Enrollment target: 924 to 758
    • Eligibility criteria expanded, about 4 words
    v11
  29. Study sites: 152 to 157v10
  30. Study sites: 150 to 152v9
  31. Study sites: 147 to 150v8
  32. Study sites: 138 to 147v7
  33. Study sites: 107 to 138
    • Study completion date: Jul 2026
    v6
  34. Study sites: 85 to 107v5
  35. Study sites: 49 to 85
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints reordered
    • Study description shortened, about 6 words
    v4
  36. Study sites: 2 to 49
    • Interventions: cisplatin (Drug), clinical observation (Other), fluorouracil (Drug), gemcitabine hydrochloride (Drug), intensity-modulated radiation… to Cisplatin (Drug), Clinical Observation (Other), Fluorouracil (Drug), Gemcitabine Hydrochloride (Drug), Intensity-Modulated Radiation…
    • Eligibility criteria expanded, about 53 words
    v3
  37. Lead sponsor: Radiation Therapy Oncology Group to NRG Oncologyv2
  1. Study First Submitted
  • 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
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There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Trial Details
NCT Number NCT02135042
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 EBV Infection, Stage II Nasopharyngeal Carcinoma AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage IVB Nasopharyngeal Carcinoma AJCC v7
Related terms Epstein-Barr Virus Infections, Nasopharyngeal Carcinoma
Enrollment 924 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov