Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy
| Group | Value (percentage of participants) |
|---|---|
| RT, Docetaxel, Hormonal Therapy | 26 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer
NCT00669162Aug 2012 to Apr 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).
Experimental
RT, Docetaxel, Hormonal Therapy
Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)
Outcomes the sponsor listed as primary.
Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy
Time frame · 8 Months
Defined as percentage of patients that complete full dose of Radiation Therapy (RT)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| RT, Docetaxel, Hormonal Therapy | 26 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| RT, Docetaxel, Hormonal TherapyRadiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) Docetaxel: 20mg/m2 IV weekly for 7 weeks Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) | 0 / 27 | 3 / 27 | 27 / 27 |
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