A Phase 3 interventional study of hypofraction and convention in Prostate Cancer, sponsored by Beijing Hospital. Status unknown at 1 site in China. Open to male participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Beijing Hospital · Phase 3, Interventional, and Treatment
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
70 Gy in 28 fractions over 5.6 weeks
Radiation: hypofraction
80Gy in 40 fractions over 8 weeks
Radiation: convention
70 Gy in 28 fractions over 5.6 weeks
80Gy in 40 fractions over 8 weeks
Biochemical progression free survival
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
Time frame: up to 18 months
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Time frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Time frame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
Overall Survival
Time frame: up to 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Beijing Hospital