CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,534 enrolled
Drug / intervention
70.2 Gy 3D-CRT/IMRT +1 moreradiation
Likely dose
79.2 Gy in 44 fractions (high-dose arm) or 70.2 Gy in 39 fractions (standard-dose arm) via 3D-CRT/IMRTAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed adenocarcinoma of the prostate
  • ✓Clinical stage T1b–T2b
  • ✓Gleason score 2–6 with PSA ≥10 to <20 ng/mL, OR Gleason score 7 with PSA <15 ng/mL
  • ✓No regional lymph node involvement
Key exclusion· 4
  • ✕Other invasive malignancy within past 5 years except localized basal cell or squamous cell skin cancer
  • ✕Major medical or psychiatric illness precluding study participation
  • ✕Prior pelvic irradiation or brachytherapy
  • ✕Prior radical prostatectomy, cryosurgery, or bilateral orchiectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00033631
NCT00033631Phase 3Completed
CompareCT.gov

A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer

Radiation Therapy Oncology Group·interventional·Posted Jan 27, 2003·Updated Jan 18, 2023

In Brief

A Phase 3 clinical trial evaluating 70.2 Gy 3D-CRT/IMRT and 79.2 Gy 3D-CRT/IMRT for Prostate Cancer. Completed, enrolled 1,534 participants across 86 sites in 2 countries.

Detailed Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2002
Primary CompletionApr 1, 2014
Study CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 23.4 years ago

Interventions

70.2 Gy 3D-CRT/IMRTradiation

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

79.2 Gy 3D-CRT/IMRTradiation

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.