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Trial record 13 of 1543 for:    Androgens

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer (CHAARTED)

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: NCT00309985
Recruitment Status : Active, not recruiting
First Posted : April 3, 2006
Results First Posted : March 3, 2016
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Hormone-sensitive Prostate Cancer
Interventions Drug: androgen-deprivation therapy
Drug: docetaxel
Enrollment 790
Recruitment Details This study was activated on July 28, 2006 and closed to accrual on November 21, 2012, after accrual of 790 patients.
Pre-assignment Details  
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Period Title: Overall Study
Started 397 393
Toxicity Analysis 390 392
Both Baseline and 3-month FACT-P Evals 334 299
Completed 335 392 [1]
Not Completed 62 1
Reason Not Completed
Disease progression             12             0
Adverse Event             30             0
Death             2             0
Withdrawal by Subject             5             1
Physician Decision             3             0
Never started treatment             7             0
Complicating disease             1             0
Non-compliance             1             0
Chemotherapy discontinued only             1             0
[1]
Arm B tx info was not collected so only 1 patient w/o follow-up data was considered "not completed".
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone Total
Hide Arm/Group Description Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Total of all reporting groups
Overall Number of Baseline Participants 397 393 790
Hide Baseline Analysis Population Description
All randomized patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 397 participants 393 participants 790 participants
64
(36 to 88)
63
(39 to 91)
63
(36 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants 393 participants 790 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
397
 100.0%
393
 100.0%
790
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 397 393
Median (95% Confidence Interval)
Unit of Measure: months
57.6
(49.1 to 72.8)
44.0
(34.4 to 49.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
Comments The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Time to Clinical Progression
Hide Description Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 397 393
Median (95% Confidence Interval)
Unit of Measure: months
33.0
(27.3 to 41.2)
19.8
(17.9 to 22.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
Hide Description Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 397 393
Median (95% Confidence Interval)
Unit of Measure: months
20.2
(17.2 to 23.6)
11.7
(10.8 to 14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients With PSA Complete Response (CR) at 6 Months
Hide Description PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Time Frame Assessed at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 397 393
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.320
(0.274 to 0.369)
0.196
(0.158 to 0.239)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Patients With PSA Complete Response (CR) at 12 Months
Hide Description PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Time Frame Assessed at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 397 393
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.277
(0.234 to 0.324)
0.168
(0.132 to 0.209)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title QOL Change From Baseline to 3 Months
Hide Description The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy – Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Time Frame Assessed at baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with both baseline and 3-month QOL assessments are included in this analysis.
Arm/Group Title Androgen-Deprivation Therapy and Docetaxel Androgen-Deprivation Therapy Alone
Hide Arm/Group Description:
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed 334 299
Mean (Standard Error)
Unit of Measure: units on a scale
-2.7  (0.9) -1.1  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy and Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Androgen-Deprivation Therapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description Submission of late adverse events is required at follow-up visits up to 10 years.
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   116/390 (29.74%)   12/392 (3.06%) 
Blood and lymphatic system disorders     
Anemia  1  5/390 (1.28%)  1/392 (0.26%) 
Febrile neutropenia  1  24/390 (6.15%)  0/392 (0.00%) 
Cardiac disorders     
Left ventricular diastolic dysfunction  1  1/390 (0.26%)  0/392 (0.00%) 
Left ventricular systolic dysfunction  1  0/390 (0.00%)  1/392 (0.26%) 
Cardiac/heart, pain  1  1/390 (0.26%)  0/392 (0.00%) 
Ear and labyrinth disorders     
Tinnitus  1  1/390 (0.26%)  0/392 (0.00%) 
Gastrointestinal disorders     
Constipation  1  1/390 (0.26%)  0/392 (0.00%) 
Diarrhea w/o prior colostomy  1  4/390 (1.03%)  0/392 (0.00%) 
Dyspepsia  1  1/390 (0.26%)  0/392 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  2/390 (0.51%)  0/392 (0.00%) 
Nausea  1  2/390 (0.51%)  0/392 (0.00%) 
Vomiting  1  2/390 (0.51%)  0/392 (0.00%) 
Abdomen, pain  1  1/390 (0.26%)  0/392 (0.00%) 
General disorders     
Fatigue  1  16/390 (4.10%)  1/392 (0.26%) 
Death NOS  1  1/390 (0.26%)  0/392 (0.00%) 
Edema limb  1  1/390 (0.26%)  0/392 (0.00%) 
Immune system disorders     
Allergic reaction  1  8/390 (2.05%)  0/392 (0.00%) 
Infections and infestations     
Infection w/ gr3-4 neut, heart  1  1/390 (0.26%)  0/392 (0.00%) 
Infection w/ gr3-4 neut, lung  1  1/390 (0.26%)  0/392 (0.00%) 
Infection w/ gr3-4 neut, skin  1  1/390 (0.26%)  0/392 (0.00%) 
Infection w/ gr3-4 neut, upper airway  1  2/390 (0.51%)  0/392 (0.00%) 
Infection w/ gr3-4 neut, urinary tract  1  1/390 (0.26%)  0/392 (0.00%) 
Infection Gr0-2 neut, rectum  1  1/390 (0.26%)  0/392 (0.00%) 
Infection Gr0-2 neut, skin  1  1/390 (0.26%)  0/392 (0.00%) 
Infection w/ gr3-4 neut, blood  1  1/390 (0.26%)  0/392 (0.00%) 
Infection-other  1  1/390 (0.26%)  0/392 (0.00%) 
Injury, poisoning and procedural complications     
Vascular access,Thrombosis/embolism  1  0/390 (0.00%)  1/392 (0.26%) 
Investigations     
Leukocytes decreased  1  18/390 (4.62%)  0/392 (0.00%) 
Lymphopenia  1  9/390 (2.31%)  0/392 (0.00%) 
Neutrophils decreased  1  47/390 (12.05%)  0/392 (0.00%) 
Platelets decreased  1  1/390 (0.26%)  0/392 (0.00%) 
Weight gain  1  2/390 (0.51%)  0/392 (0.00%) 
Alkaline phosphatase increased  1  2/390 (0.51%)  1/392 (0.26%) 
Alanine aminotransferase increased  1  1/390 (0.26%)  0/392 (0.00%) 
Creatinine increased  1  1/390 (0.26%)  0/392 (0.00%) 
Metabolism and nutrition disorders     
Pancreatic glucose intolerance  1  0/390 (0.00%)  1/392 (0.26%) 
Anorexia  1  0/390 (0.00%)  2/392 (0.51%) 
Dehydration  1  2/390 (0.51%)  0/392 (0.00%) 
Hyperglycemia  1  3/390 (0.77%)  0/392 (0.00%) 
Hyperkalemia  1  1/390 (0.26%)  1/392 (0.26%) 
Hyponatremia  1  2/390 (0.51%)  0/392 (0.00%) 
Musculoskeletal and connective tissue disorders     
Nonneuropathic generalized weakness  1  4/390 (1.03%)  0/392 (0.00%) 
Back, pain  1  1/390 (0.26%)  0/392 (0.00%) 
Bone, pain  1  2/390 (0.51%)  1/392 (0.26%) 
Joint, pain  1  1/390 (0.26%)  0/392 (0.00%) 
Muscle, pain  1  3/390 (0.77%)  1/392 (0.26%) 
Nervous system disorders     
Neuropathy-motor  1  2/390 (0.51%)  0/392 (0.00%) 
Neuropathy-sensory  1  2/390 (0.51%)  1/392 (0.26%) 
Syncope  1  1/390 (0.26%)  0/392 (0.00%) 
Head/headache  1  0/390 (0.00%)  1/392 (0.26%) 
Reproductive system and breast disorders     
Erectile impotence  1  1/390 (0.26%)  2/392 (0.51%) 
Gynecomastia  1  1/390 (0.26%)  1/392 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/390 (0.26%)  0/392 (0.00%) 
Dyspnea  1  2/390 (0.51%)  2/392 (0.51%) 
Hiccoughs  1  1/390 (0.26%)  0/392 (0.00%) 
Skin and subcutaneous tissue disorders     
Nail changes  1  1/390 (0.26%)  0/392 (0.00%) 
Skin-other  1  1/390 (0.26%)  0/392 (0.00%) 
Vascular disorders     
Hypertension  1  1/390 (0.26%)  1/392 (0.26%) 
Hot flashes  1  1/390 (0.26%)  1/392 (0.26%) 
Thrombosis/thrombus/embolism  1  3/390 (0.77%)  1/392 (0.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   38/390 (9.74%)   1/392 (0.26%) 
General disorders     
Fatigue  1  35/390 (8.97%)  1/392 (0.26%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  22/390 (5.64%)  0/392 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Certain Agreements
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Scott E. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Department of Medicine; Department of Biostatistics and Computational Biology; Dana-Farber Cancer Institute, Boston; Harvard Medical School, Boston; Johns Hopkins University, Baltimore; University of Wisconsin Carbone Cancer Center; School of Medicine and Public Health; Madison; Fox Chase Cancer Center, Temple University Health System, Philadelphia; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis; Mayo Clinic, Rochester, MN; University Hospitals Case Medical Center, Seidman Cancer Center; Cleveland Clinic Taussig Cancer Institute; Both in Cleveland; University of Virginia Cancer Center, Charlottesville; Comprehensive Cancer Centers of Nevada, Las Vegas; Siteman Cancer Center, Washington University School of Medicine, St. Louis; NorthShore University Health System, Evanston, IL; University of Michigan Comprehensive Cancer Center, Ann Arbor; Rutgers Cancer Institute of New Jersey, New Brunswick.N Engl J Med. 2015 Aug 20;373(8):737-46. [Epub 2015 Aug 5]. doi: 10.1056/NEJMoa1503747. Urol Oncol. 2017 Mar;35(3):123. doi: 10.1016/j.urolonc.2016.12.021. Epub 2017 Feb 1.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00309985     History of Changes
Other Study ID Numbers: E3805
E3805 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180794 ( U.S. NIH Grant/Contract )
First Submitted: March 29, 2006
First Posted: April 3, 2006
Results First Submitted: December 17, 2015
Results First Posted: March 3, 2016
Last Update Posted: September 24, 2019