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Tracking Information | |||||||||
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First Received Date † | March 29, 2006 | ||||||||
Last Updated Date | May 12, 2009 | ||||||||
Start Date † | July 2006 | ||||||||
Current Primary Outcome Measures † |
Overall survival [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00309985 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer | ||||||||
Official Title † | CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer [CHAARTED] | ||||||||
Brief Summary | RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen ablation therapy and chemotherapy to see how well they work compared to androgen ablation therapy alone in treating patients with metastatic prostate cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs < 70), ECOG performance status (0-1 vs 2), combined androgen blockade for > 30 days (yes vs no), duration of prior adjuvant hormonal therapy (> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for up to 10 years. PROJECTED ACCRUAL: A total of 568 patients will be accrued for this study. |
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized | ||||||||
Condition † | Prostate Cancer | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 600 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | April 2024 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Male | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00309985 | ||||||||
Responsible Party | Robert L. Comis, ECOG Group Chair's Office | ||||||||
Secondary IDs †† | ECOG-E3805 | ||||||||
Study Sponsor † | Eastern Cooperative Oncology Group | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | May 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |