Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00016913
First received: June 6, 2001
Last updated: July 1, 2016
Last verified: July 2016
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: carboplatin
Drug: estramustine
Drug: paclitaxel
Radiation: radiation therapy
Drug: leuprolide or goserelin acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.

Reporting Groups
  Description
Neo-Adj ChemoTx + Ablation Prior to RT Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer

Participant Flow:   Overall Study
    Neo-Adj ChemoTx + Ablation Prior to RT  
STARTED     27  
COMPLETED     27  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Neo-Adj ChemoTx + Ablation Prior to RT Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer

Baseline Measures
    Neo-Adj ChemoTx + Ablation Prior to RT  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Median (Full Range)
  61  
  (52 to 75)  
Gender  
[units: participants]
 
Female     0  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     27  



  Outcome Measures
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1.  Primary:   Toxicity   [ Time Frame: 90 days and 1 year post treatment ]

2.  Secondary:   Time to Prostate-specific Antigen Failure   [ Time Frame: PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years). ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: registration to progression, up to 5.5 years from registration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wm. Kevin Kelly, DO
Organization: Department of Medicine, Memorial Sloan-Kettering Cancer Center
e-mail: kellyw@mskcc.org


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00016913     History of Changes
Other Study ID Numbers: CALGB-99811
U10CA031946 ( US NIH Grant/Contract Award Number )
CDR0000068632 ( Registry Identifier: NCI Physician Data Query )
Study First Received: June 6, 2001
Results First Received: July 31, 2015
Last Updated: July 1, 2016
Health Authority: United States: Federal Government