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A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate CancerUnique Dataset IDnci-data-383ClinicalTrial.gov IDNCT00033631
Clinical Trial Title
A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Trial Summary and Conditions
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.
See data dictionary for more details.
OBJECTIVES: Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy. Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. Compare the probability of tumor control and normal tissue complications in patients treated with these regimens. Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens. Compare the quality of life, including sexual function, of patients treated with these regimens. Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA greater than or equal to 10 mg/mL but less than 20 ng/mL vs Gleason score 7, PSA less than 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days). Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days). Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.
Primary: Overall Survival [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. ] Secondary: Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition [ Time Frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. ] Disease Specific Survival [ Time Frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. ] Local Progression [ Time Frame: From randomization to date of failure (local progression) or death or last follow-up. ] Distant Metastases [ Time Frame: From randomization to date of failure (distant metastasis) or death or last follow-up. ] Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity [ Time Frame: From the start of treatment to 90 days. ] Erectile Function by International Index of Erectile Function (IIEF) [ Time Frame: From randomization to 5 years. ] Global Quality of Life (QOL) by Spitzer QOL Index (SQLI) [ Time Frame: From randomization to 5 years. ] Quality Adjusted Survival by SQLI [ Time Frame: From randomization to 5 years. ] Tumor Control Probability [ Time Frame: From randomization to date of failure (tumor progression) or last follow-up. ] Normal Tissue Complication Probability [ Time Frame: From randomization to last follow-up. ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
This dataset will allow users to reproduce the treatment comparison between arms in trial NCT00033631.
Available Downloads: NCT00033631-D1
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00033631-D1-Data-Dictionary.pdf