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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00667888 |
Condition | Intervention | Phase |
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Prostate Cancer |
Radiation: Conventional Fractionated Intensity Modulated Radiotherapy Radiation: Hypofractionated Intensity Modulated Radiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation |
Estimated Enrollment: | 225 |
Study Start Date: | January 2001 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Intensity Modulated Radiotherapy (IMRT)
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Radiation: Conventional Fractionated Intensity Modulated Radiotherapy
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
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2: Experimental
Hypofractionated Intensity Modulated Radiotherapy (HIMRT)
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Radiation: Hypofractionated Intensity Modulated Radiotherapy
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
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Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.
Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.
Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.
Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.
After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.
This is an investigational treatment. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Deborah A. Kuban, MD | 713-563-2300 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Deborah A. Kuban, MD |
Principal Investigator: | Deborah A. Kuban, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Deborah A. Kuban, MD/Professor ) |
Study ID Numbers: | ID00-381 |
Study First Received: | April 24, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00667888 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Radiation Radiotherapy Intensity Modulated Radiotherapy |
IMRT Hypofractionated Intensity Modulated Radiotherapy HIMRT |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |