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Trial record 23 of 23 for:    CD20 Fred Hutchinson

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00070018
Recruitment Status : Active, not recruiting
First Posted : October 7, 2003
Results First Posted : April 3, 2012
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Drug: Cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
Biological: Yttrium-90 ibritumomab tiuxetan
Biological: Indium-111 ibritumomab tiuxetan
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHOP + RT + Zevalin
Hide Arm/Group Description Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Period Title: Overall Study
Started 46
Eligible 46
Eligible and Began Protocol Therapy 46
Completed 42
Not Completed 4
Reason Not Completed
Adverse Event             2
Lack of Efficacy             1
Withdrawal by Subject             1
Arm/Group Title CHOP + RT + Zevalin
Hide Arm/Group Description Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
61.2
(23.5 to 84.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
16
  34.8%
Male
30
  65.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Hispanic or Latino
3
   6.5%
Not Hispanic or Latino
38
  82.6%
Unknown or Not Reported
5
  10.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.5%
White
42
  91.3%
More than one race
1
   2.2%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time Frame at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CHOP + RT + Zevalin
Hide Arm/Group Description:
Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89
(76 to 95)
Time Frame After each cycle of CHOP, after RT, and 3 months after Zevalin therapy for a maximum of 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CHOP + RT + Zevalin
Hide Arm/Group Description Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
All-Cause Mortality
CHOP + RT + Zevalin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CHOP + RT + Zevalin
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CHOP + RT + Zevalin
Affected / at Risk (%)
Total   44/46 (95.65%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  4/46 (8.70%) 
Hemoglobin  1  28/46 (60.87%) 
Gastrointestinal disorders   
Constipation  1  16/46 (34.78%) 
Diarrhea  1  9/46 (19.57%) 
Dry mouth/salivary gland (xerostomia)  1  10/46 (21.74%) 
Dysphagia (difficulty swallowing)  1  6/46 (13.04%) 
Esophagitis  1  3/46 (6.52%) 
Heartburn/dyspepsia  1  5/46 (10.87%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  5/46 (10.87%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  8/46 (17.39%) 
Nausea  1  21/46 (45.65%) 
Pain - Oral cavity  1  4/46 (8.70%) 
Vomiting  1  11/46 (23.91%) 
General disorders   
Edema: limb  1  3/46 (6.52%) 
Fatigue (asthenia, lethargy, malaise)  1  33/46 (71.74%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)  1  4/46 (8.70%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  3/46 (6.52%) 
Injury, poisoning and procedural complications   
Rash: dermatitis associated with radiation - Radiation  1  16/46 (34.78%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  6/46 (13.04%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  8/46 (17.39%) 
Bilirubin (hyperbilirubinemia)  1  3/46 (6.52%) 
Creatinine  1  3/46 (6.52%) 
Leukocytes (total WBC)  1  29/46 (63.04%) 
Lymphopenia  1  19/46 (41.30%) 
Neutrophils/granulocytes (ANC/AGC)  1  27/46 (58.70%) 
Platelets  1  25/46 (54.35%) 
Weight loss  1  8/46 (17.39%) 
Metabolism and nutrition disorders   
Anorexia  1  7/46 (15.22%) 
Dehydration  1  4/46 (8.70%) 
Glucose, serum-high (hyperglycemia)  1  12/46 (26.09%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  5/46 (10.87%) 
Pain - Bone  1  3/46 (6.52%) 
Pain - Muscle  1  5/46 (10.87%) 
Nervous system disorders   
Dizziness  1  5/46 (10.87%) 
Neuropathy: sensory  1  14/46 (30.43%) 
Pain - Head/headache  1  6/46 (13.04%) 
Taste alteration (dysgeusia)  1  3/46 (6.52%) 
Psychiatric disorders   
Mood alteration - depression  1  3/46 (6.52%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/46 (8.70%) 
Dyspnea (shortness of breath)  1  3/46 (6.52%) 
Mucositis/stomatitis (clinical exam) - Pharynx  1  3/46 (6.52%) 
Mucositis/stomatitis (functional/symptomatic) - Pharynx  1  5/46 (10.87%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  4/46 (8.70%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify)  1  4/46 (8.70%) 
Hair loss/Alopecia (scalp or body)  1  24/46 (52.17%) 
Rash/desquamation  1  8/46 (17.39%) 
Vascular disorders   
Hypotension  1  3/46 (6.52%) 
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 NOT 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: SWOG Statistical Center
Phone: 206-667-4623
Publications of Results:
Miller TP, Unger JM, Spier C, et al.: Effect of adding ibritumomab tiuxetan (Zevalin) radioimmunotherapy consolidation to three cycles of CHOP plus involved-field radiotherapy for limited-stage aggressive diffuse B-cell lymphoma (SWOG 0313). [Abstract] Blood 112 (11): A-3598, 2008.
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00070018     History of Changes
Other Study ID Numbers: CDR0000329864
U10CA032102 ( U.S. NIH Grant/Contract )
S0313 ( Other Identifier: SWOG )
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: March 5, 2012
Results First Posted: April 3, 2012
Last Update Posted: January 3, 2019