A Prospective Randomized Phase II Clinical Trial of Moderately Hypofractionated Radiotherapy (70 Gy in 28 Fractions vs 60 Gy in 20 Fractions) Using Helical Tomotherapy.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- Tatarstan Cancer Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Biochemical Relapse Free Survival Rate
- Status
- Enrolling By Invitation
- Last Updated
- 7 years ago
Overview
Brief Summary
Radiation therapy is one of the standard treatments for men with prostate cancer. Moderately hypofractionated radiotherapy has been established to be equivalent to standard fractionated radiotherapy in several large randomized clinical trials, however different hypofractionated regimens have been used in these studies. The two most common hypofractionated regimens are 70 Gy in 28 fractions and 60 Gy in 20 fractions, both are considered standard of care, however it is not unknown which regimen is better in terms of effectiveness and toxicity. The aim of this randomized controlled clinical trial is to compare the two hypofractionated radiotherapy regimens using Helical Tomotherapy.
Detailed Description
OBJECTIVES: Primary Compare the biochemical relapse free survival (DFS) of patients with prostate cancer treated with hypofractionated regimens 70 Gy in 28 fractions and 60 Gy in 20 fractions intensity-modulated radiotherapy (IMRT) using helical Tomotherapy. Secondary Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens. Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to TNM ( T1-3N0M0), Gleason score (6,7 (3+4), 7(4+3), 8). Before radiotherapy patients receive hormone therapy from 3 months to 6 months. Patients are randomized to 1 of 2 treatment arms. Arm 1 hypofractionated dosing 28 fractions x 2,5 Gy over 38 days (prostate 28 x 2,5Gy - 70Gy, seminal vesicles 28 x 2Gy - 56 Gy, node lympaticus ( if Rouch formula\> 15% or N1) 28 x 1,8 Gy - 50,4 Gy). Arm II hypofractionated dosing 20 fractions x 3 Gy over 26day (prostate 20 x 3Gy - 60Gy, seminal vesicles 20 x 2,5Gy - 50 Gy, node lympaticus ( if if Rouch formula\> 15% or N1 ) 20 x 2,2 Gy - 44 Gy). After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Biochemical Relapse Free Survival Rate
Time Frame: Analysis occurs after all patients have been followed for ten year.
Determine what regime of hypofractionation will be the best 5-10 year biochemical disease free survival. Compare the results of hypofractional regimes (60Gy in 20 farctions; 70 Gy in 28 farctions).
Secondary Outcomes
- Five year Quality of life measured with EQ5D.(Analysis occurs after all patients have been followed for five year.)
- Five year Local Progression Rate(Analysis occurs after all patients have been followed for five year.)
- Ten year Local Progression Rate(Analysis occurs after all patients have been followed for ten year.)
- Five year Quality of life measured with EPIС СP.(Analysis occurs after all patients have been followed for five year.)
- Five year Overall Survival Rate(Analysis occurs after all patients have been followed for five year.)
- Ten year Overall Survival Rate(Analysis occurs after all patients have been followed for ten year.)
- Frequency of Patients With GU and GI Acute and Late Toxicity(Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.)
- Ten year Quality of life measured with EQ5D.(Analysis occurs after all patients have been followed for ten year.)
- Ten year Quality of life measured with EPIС СP.(Analysis occurs after all patients have been followed for ten year.)