Radiation Therapy in Treating Patients With Stage II Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00033631 |
Recruitment Status :
Active, not recruiting
First Posted : January 27, 2003
Results First Posted : February 8, 2017
Last Update Posted : May 19, 2020
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Sponsor:
Radiation Therapy Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Interventions |
Radiation: 70.2 Gy 3D-CRT/IMRT Radiation: 79.2 Gy 3D-CRT/IMRT |
Enrollment | 1532 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 70.2 Gy | 79.2 Gy |
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70.2 Gy 3D-CRT/IMRT: 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/IMRT: 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. |
Period Title: Overall Study | ||
Started | 769 | 763 |
Completed | 751 [1] | 748 [1] |
Not Completed | 18 | 15 |
Reason Not Completed | ||
Protocol Violation | 14 | 11 |
Withdrawal by Subject | 4 | 4 |
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
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Baseline Characteristics
Arm/Group Title | 70.2 Gy | 79.2 Gy | Total | |
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70.2 Gy 3D-CRT/IMRT: 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/IMRT: 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 751 | 748 | 1499 | |
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All eligible patients who did not withdraw consent
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 751 participants | 748 participants | 1499 participants | |
71
(33 to 86)
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71
(49 to 87)
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71
(33 to 87)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 751 participants | 748 participants | 1499 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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|
Male |
751 100.0%
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748 100.0%
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1499 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
The data monitoring committee (DMC) recommended early reporting of the trial when the third interim analysis futility boundary was crossed.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: | Wendy Seiferheld, M.S. |
Organization: | NRG Oncology |
EMail: | seiferheldw@nrgoncology.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Radiation Therapy Oncology Group |
ClinicalTrials.gov Identifier: | NCT00033631 |
Other Study ID Numbers: |
RTOG-0126 CDR0000069306 |
First Submitted: | April 9, 2002 |
First Posted: | January 27, 2003 |
Results First Submitted: | December 16, 2016 |
Results First Posted: | February 8, 2017 |
Last Update Posted: | May 19, 2020 |