Radiation Oncology/RTOG Trials/0126

RTOG 01-26 (PROSTATE)

• Title: A Phase III Randomized Study of High Dose 3D-CRT/IMRT vs. Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer
• Objective: Determine whether 3D-CRT/IMRT to 79.2 Gy in 44 fractions will lead to improved overall survival in patients treated for prostate cancer compared to a group of patients treated with 3D-CRT/ IMRT to 70.2 Gy in 39 fractions.
• Protocol:
  • Arm 1: 3D-CRT or IMRT: 70.2 Gy in 39 fractions
  • Arm 2: 3D-CRT or IMRT: 79.2 Gy in 44 fractions
• Eligibility:
  • cT1b-T2b,
  • (GS 2-6 and PSA 10-20) or (GS 7 and PSA <15)
  • N0M0
• Enrollment Target: 1520 patients
• Activation: March 21, 2002
• Closed: Aug 20, 2008
• Additional Information:
  • Meeting Minutes January 2005 - "Dr. Michalski updated the group regarding RTOG 0126. Accrual for this study has improved over the past six months."
  • Meeting Minutes June 2004 - "The randomized prostate cancer trial (RTOG 0126) had the IMRT amendment approved by the NCI last fall. Accrual has improved this past meeting cycle."
  • Meeting Minutes January 2004 - "The randomized prostate cancer trial (RTOG 0126) had the IMRT amendment approved by the NCI last fall. Accrual to the study has slowed while institutions submit the amendment to their IRB’s and complete credentialing requirements for IMRT. It is expected that accrual to this study will pick up once the regulatory requirements have been completed at the participating institutions and once RTOG 9910 closed to accrual."
  • Meeting Minutes June 2003 - "Dr. Michalski reported that RTOG 0126, the randomized trial of high dose versus standard dose conformal radiation therapy for intermediate prostate cancer would soon allow IMRT. The decision was made to drop the need for two separate target volumes for patients receiving IMRT. Instead, a single target volume that encompasses the proximal seminal vesicles will be used. For patients treated with forward planned 3DCRT, an optional volume reduction after 55.8 Gy will be allowed. The prescription point was changed to a minimum dose to the PTV, rather than an ICRU reference dose."