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Trial record 62 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

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: NCT00088881
Recruitment Status : Terminated
First Posted : August 5, 2004
Results First Posted : February 18, 2015
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: rituximab
Drug: prednisone
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: radiation therapy
Procedure: positron emission tomography
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Period Title: Step 1 - R-CHOP
Started 62
Eligible and Treated 53
Completed 48
Not Completed 14
Reason Not Completed
Patient ineligible             9
Adverse Event             1
Withdrawal by Subject             2
Physician Decision             1
Insurance company refused to cover             1
Period Title: Step 2 - Zevalin™ Radioimmunotherapy
Started 56 [1]
Eligible and Treated 48
Completed 45
Not Completed 11
Reason Not Completed
Patient ineligible             8
Other             3
[1]
This includes all patients who received step 2 treatment regardless of eligibility.
Period Title: Step 3 - Radiation Therapy
Started 1
Completed 1
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants
62
(20 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
21
  39.6%
Male
32
  60.4%
1.Primary Outcome
Title Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Hide Description Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Time Frame Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment
Hide Arm/Group Description:

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.87
(0.75 to 0.95)
2.Primary Outcome
Title Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Hide Description Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.
Time Frame Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Treatment
Hide Arm/Group Description:

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.89
(0.77 to 0.96)
3.Secondary Outcome
Title 3-year Time to Treatment Failure (TTF) Rate
Hide Description Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.
Time Frame Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment
Hide Arm/Group Description:

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.92
(0.84 to 1.00)
4.Secondary Outcome
Title 3-year Overall Survival (OS) Rate
Hide Description Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment
Hide Arm/Group Description:

R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.

Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.

Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.98
(0.94 to 1.00)
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Step 1 - R-CHOP Step 2 - Zevalin™ Radioimmunotherapy Step 3 - Radiation Therapy
Hide Arm/Group Description Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study. Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
All-Cause Mortality
Step 1 - R-CHOP Step 2 - Zevalin™ Radioimmunotherapy Step 3 - Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Step 1 - R-CHOP Step 2 - Zevalin™ Radioimmunotherapy Step 3 - Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/62 (70.97%)   46/56 (82.14%)   0/1 (0.00%) 
Blood and lymphatic system disorders       
Anemia  1  5/62 (8.06%)  3/56 (5.36%)  0/1 (0.00%) 
Febrile neutropenia  1  10/62 (16.13%)  0/56 (0.00%)  0/1 (0.00%) 
Cardiac disorders       
Heart block Stokes-Adams syndrome  1  0/62 (0.00%)  0/56 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders       
Diarrhea w/o prior colostomy  1  1/62 (1.61%)  1/56 (1.79%)  0/1 (0.00%) 
Dyspepsia  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Muco/stomatitis (symptom) oral cavity  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Nausea  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Vomiting  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
General disorders       
Fatigue  1  7/62 (11.29%)  0/56 (0.00%)  0/1 (0.00%) 
Face, pain  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Immune system disorders       
Allergic reaction  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Infections and infestations       
Infection w/ gr3-4 neut, lung  1  2/62 (3.23%)  0/56 (0.00%)  0/1 (0.00%) 
Infection w/ gr3-4 neut, skin  1  0/62 (0.00%)  1/56 (1.79%)  0/1 (0.00%) 
Infection w/ gr3-4 neut, blood  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Investigations       
CD4 decreased  1  0/62 (0.00%)  1/56 (1.79%)  0/1 (0.00%) 
Leukocytes decreased  1  22/62 (35.48%)  20/56 (35.71%)  0/1 (0.00%) 
Lymphopenia  1  26/62 (41.94%)  34/56 (60.71%)  0/1 (0.00%) 
Neutrophils decreased  1  27/62 (43.55%)  29/56 (51.79%)  0/1 (0.00%) 
Platelets decreased  1  5/62 (8.06%)  26/56 (46.43%)  0/1 (0.00%) 
Creatinine increased  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  4/62 (6.45%)  0/56 (0.00%)  0/1 (0.00%) 
Dehydration  1  2/62 (3.23%)  1/56 (1.79%)  0/1 (0.00%) 
Acidosis  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Hypocalcemia  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Hyperglycemia  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Hypoglycemia  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Hypomagnesemia  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Hypophosphatemia  1  2/62 (3.23%)  0/56 (0.00%)  0/1 (0.00%) 
Hypokalemia  1  2/62 (3.23%)  0/56 (0.00%)  0/1 (0.00%) 
Hyponatremia  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders       
Nonneuropathic generalized weakness  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Nervous system disorders       
Neuropathy-sensory  1  3/62 (4.84%)  1/56 (1.79%)  0/1 (0.00%) 
Syncope  1  3/62 (4.84%)  0/56 (0.00%)  0/1 (0.00%) 
Neuropathic, pain  1  0/62 (0.00%)  1/56 (1.79%)  0/1 (0.00%) 
Psychiatric disorders       
Psychosis  1  2/62 (3.23%)  0/56 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders       
Bladder, pain  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  2/62 (3.23%)  0/56 (0.00%)  0/1 (0.00%) 
Pulmonary/Upper Respiratory-other  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders       
Nail changes  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
Vascular disorders       
Hypotension  1  1/62 (1.61%)  0/56 (0.00%)  0/1 (0.00%) 
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%
Step 1 - R-CHOP Step 2 - Zevalin™ Radioimmunotherapy Step 3 - Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/62 (100.00%)   55/56 (98.21%)   0/1 (0.00%) 
Blood and lymphatic system disorders       
Anemia  1  48/62 (77.42%)  44/56 (78.57%)  0/1 (0.00%) 
Gastrointestinal disorders       
Constipation  1  35/62 (56.45%)  0/56 (0.00%)  0/1 (0.00%) 
Diarrhea w/o prior colostomy  1  16/62 (25.81%)  6/56 (10.71%)  0/1 (0.00%) 
Dry mouth  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Dyspepsia  1  19/62 (30.65%)  0/56 (0.00%)  0/1 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  14/62 (22.58%)  0/56 (0.00%)  0/1 (0.00%) 
Muco/stomatitis (symptom) oral cavity  1  17/62 (27.42%)  0/56 (0.00%)  0/1 (0.00%) 
Nausea  1  37/62 (59.68%)  6/56 (10.71%)  0/1 (0.00%) 
Vomiting  1  15/62 (24.19%)  0/56 (0.00%)  0/1 (0.00%) 
Abdomen, pain  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
General disorders       
Fatigue  1  50/62 (80.65%)  32/56 (57.14%)  0/1 (0.00%) 
Fever w/o neutropenia  1  0/62 (0.00%)  3/56 (5.36%)  0/1 (0.00%) 
Rigors/chills  1  7/62 (11.29%)  0/56 (0.00%)  0/1 (0.00%) 
Edema limb  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Investigations       
Leukocytes decreased  1  39/62 (62.90%)  51/56 (91.07%)  0/1 (0.00%) 
Lymphopenia  1  50/62 (80.65%)  47/56 (83.93%)  0/1 (0.00%) 
Neutrophils decreased  1  28/62 (45.16%)  41/56 (73.21%)  0/1 (0.00%) 
Platelets decreased  1  20/62 (32.26%)  51/56 (91.07%)  0/1 (0.00%) 
Weight loss  1  11/62 (17.74%)  3/56 (5.36%)  0/1 (0.00%) 
Alkaline phosphatase increased  1  13/62 (20.97%)  8/56 (14.29%)  0/1 (0.00%) 
Alanine aminotransferase increased  1  4/62 (6.45%)  0/56 (0.00%)  0/1 (0.00%) 
Aspartate aminotransferase increased  1  9/62 (14.52%)  4/56 (7.14%)  0/1 (0.00%) 
Blood bilirubin increased  1  0/62 (0.00%)  3/56 (5.36%)  0/1 (0.00%) 
Creatinine increased  1  4/62 (6.45%)  0/56 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  14/62 (22.58%)  4/56 (7.14%)  0/1 (0.00%) 
Hypocalcemia  1  5/62 (8.06%)  0/56 (0.00%)  0/1 (0.00%) 
Hyperglycemia  1  44/62 (70.97%)  16/56 (28.57%)  0/1 (0.00%) 
Hypokalemia  1  4/62 (6.45%)  0/56 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders       
Joint, pain  1  4/62 (6.45%)  0/56 (0.00%)  0/1 (0.00%) 
Muscle, pain  1  9/62 (14.52%)  0/56 (0.00%)  0/1 (0.00%) 
Nervous system disorders       
Taste disturbance  1  12/62 (19.35%)  3/56 (5.36%)  0/1 (0.00%) 
Dizziness  1  7/62 (11.29%)  0/56 (0.00%)  0/1 (0.00%) 
Neuropathy-motor  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Neuropathy-sensory  1  38/62 (61.29%)  10/56 (17.86%)  0/1 (0.00%) 
Head/headache  1  8/62 (12.90%)  3/56 (5.36%)  0/1 (0.00%) 
Psychiatric disorders       
Insomnia  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  7/62 (11.29%)  0/56 (0.00%)  0/1 (0.00%) 
Dyspnea  1  8/62 (12.90%)  4/56 (7.14%)  0/1 (0.00%) 
Voice changes/dysarthria  1  0/62 (0.00%)  3/56 (5.36%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders       
Sweating  1  5/62 (8.06%)  0/56 (0.00%)  0/1 (0.00%) 
Alopecia  1  31/62 (50.00%)  7/56 (12.50%)  0/1 (0.00%) 
Pruritus/itching  1  6/62 (9.68%)  0/56 (0.00%)  0/1 (0.00%) 
Rash/desquamation  1  11/62 (17.74%)  0/56 (0.00%)  0/1 (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
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00088881     History of Changes
Other Study ID Numbers: NCI-2012-02957
E3402 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: December 16, 2014
Results First Posted: February 18, 2015
Last Update Posted: May 25, 2017