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NCT02179086

Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

StatusActive, Not Recruiting
PhasePhase 2
Primary completion

At risk: Enrollment reduced 31%, primary endpoint(s) modified.

See at-risk trials from NRG Oncology

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Record History

All 50 versions: 47 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 624 → 429 participants
    • Interventions modified
    • Study description expanded, about 152 words
    • Study sites revised (237)
  2. Eligibility criteria expanded, about 61 words
    • Study completion pushed from Dec 31, 2026 to Jul 7, 2030
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 25 of 237 sites
  3. Results posted: Aug 28, 2026v48 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Interventions modified
    • Enrollment target: estimated 606 to confirmed 624
    • Secondary endpoints: 5 to 7
    • Study description shortened, about 152 words
    • Site details revised at 1 of 237 sites
  4. Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Study sites revised (237)
    v47
  5. Primary completion date changed from estimate of Dec 31, 2025 to Jul 7, 2025v46
Show 41 earlier versionsHide 41 earlier versions
  1. Study sites revised (237)v45
  2. Secondary endpoints: 8 to 5
    • Study sites revised (237)
    v44
  3. Eligibility criteria expanded, about 493 wordsv41 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 624 to 606
    • Study sites: 239 to 237
    • Study completion date: Dec 31, 2026 to Dec 31, 2025
    • Interventions: 3-dimensional conformal radiation therapy (Radiation), intensity-modulated radiation therapy (Radiation), intensity-modulated radiation… to 3-Dimensional Conformal Radiation Therapy (Radiation), Intensity-Modulated Radiation Therapy (Radiation), Intensity-Modulated Radiation…
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 8 words
    • Collaborators: 2 to 1
  4. Study sites: 240 to 239v40
  5. Study sites revised (240)v39
  6. Primary completion date: May 2024 to Dec 31, 2025
    • Start date: Oct 27, 2014 to Dec 4, 2014
    • Study completion date: May 2026 to Dec 31, 2026
    v38
  7. Eligibility criteria revised
    • Study sites revised (240)
    v37
  8. Study sites revised (240)v36
  9. Study sites revised (240)v34
  10. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 606 to confirmed 624
    • Site details revised at 240 of 240 sites
    v33
  11. Site details revised at 21 of 240 sitesv32
  12. Study sites: 239 to 240v31
  13. Study sites: 238 to 239
    • Study description expanded, about 134 words
    v30
  14. Primary completion date: May 2021 to May 2024v29
  15. Site details revised at 3 of 238 sitesv28
  16. Study sites revised (238)v27
  17. Site details revised at 5 of 238 sitesv26
  18. Site details revised at 14 of 238 sitesv25
  19. Study sites revised (238)v24
  20. Study sites revised (238)v23
  21. Site details revised at 6 of 238 sitesv22
  22. Study sites revised (238)v21
  23. Study sites revised (238)v20
  24. Study sites: 235 to 238v19
  25. Site details revised at 7 of 235 sitesv18
  26. Primary completion date: May 2019 to May 2021
    • Study sites: 234 to 235
    • Study completion date: May 2024 to May 2026
    v17
  27. Study sites: 228 to 234v16
  28. Study sites revised (228)v15
  29. Site details revised at 141 of 228 sitesv14
  30. Study sites: 225 to 228v13
  31. Study sites: 223 to 225v12
  32. Study sites: 220 to 223v11
  33. Eligibility criteria expanded, about 1 wordv10 Show 4 more changesShow less
    • Enrollment target: 576 to 606
    • Study sites: 176 to 220
    • Study completion date: May 2024
    • Start date: Nov 2014 to Oct 27, 2014
  34. Site details revised at 1 of 176 sitesv9
  35. Study sites: 173 to 176v8
  36. Site details revised at 2 of 173 sitesv7
  37. Study sites: 156 to 173v6
  38. Study sites: 31 to 156v5
  39. Study sites revised (31)v4
  40. Study sites: 2 to 31v3
  41. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Median Survival Time (Within Center Group)
Timeframe: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Secondary (7)

Median Survival Time (Between Experimental Arms)
Median Progression-free Survival Time
Proportion of Participants With a Grade 3 or Higher Adverse Event
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 3
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 12
Show 2 moreShow less
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 3
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 12

Arms and interventions

Arm A1 (control)Active comparator

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Arm A2 (control)Active comparator

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Arm B (photon IMRT)Experimental

Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Arm C (proton beam radiation therapy)Experimental

Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Radiation: 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Photon Beam Radiation Therapy, Proton Beam Radiation Therapy

Other: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration

Drugs: Temozolomide

Sites

237 sites in 2 countries

United States 230, Canada 7