R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL (ASPIRE)
Primary Purpose
Diffuse Large B-cell Lymphoma
Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
R-CHOP
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring localized, diffuse large B-cell lymphoma, R-CHOP chemotherapy, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Histologically confirmed CD20-positive Diffuse Large B-cell Lymphoma (DLBCL), NOS
- Immunostains for CD20, CD5, CD3, CD10, MUM-1, BCL-6, BCL-2 and Ki-67 and the in situ hybridization for Epstein-Barr virus are recommended for diagnosis of DLBCL, NOS.
- No prior treatment for DLBCL
- Stage I or contiguous II disease (Involvement of two adjacent lymph node regions or organ involvement with regional lymph nodes)
- Performance status: ECOG 0-2.
- Age ≥ 18 years
- Cardiac ejection fraction ≥ 45% as measured by MUGA or 2D ECHO without clinically significant abnormalities
- Adequate renal function: serum creatinine level < 2 mg/dL
- Adequate liver functions
- Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
- Life expectancy >= 6 months
- A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
- Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
Exclusion Criteria:
- Other subtypes NHL than CD20 (+) DLBCL, NOS
- Transformed DLBCL from follicular lymphoma or other indolent lymphomas
- Bulky disease ( longest diameter >=10 cm)
- Previous treatment for DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion
- CNS involvement by lymphoma or any evidence of spinal cord compression.
- Primary Central Nervous System (CNS) DLBCL
- Primary testicular lymphoma
- Primary breast lymphoma
- Patients with a known history of HIV seropositivity or HCV (+). (Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.)
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
- Pregnant or lactating women
- Men who are not surgically sterile and women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurological or psychiatric disorders including dementia or seizures
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Total 6 cycles of R-CHOP
Total 3 cycles of R-CHOP + RT
Arm Description
Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions)
Outcomes
Primary Outcome Measures
To compare 3-year event-free survival
definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy
Secondary Outcome Measures
To evaluate and compare OS between the two arms
To evaluate and compare the ORR and CR rate
To evaluate and compare disease-free survival (DFS)
To evaluate treatment-failure pattern
Number of Participants with Adverse Events in each arm
To assess patient-reported outcomes (PROs) in both arms
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Full Information
NCT ID
NCT02054559
First Posted
January 29, 2014
Last Updated
February 20, 2016
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02054559
Brief Title
R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
Acronym
ASPIRE
Official Title
Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No consensus among trial centers regarding protocol
Study Start Date
undefined (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
localized, diffuse large B-cell lymphoma, R-CHOP chemotherapy, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total 6 cycles of R-CHOP
Arm Type
Active Comparator
Arm Title
Total 3 cycles of R-CHOP + RT
Arm Type
Experimental
Arm Description
Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions)
Intervention Type
Drug
Intervention Name(s)
R-CHOP
Intervention Description
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
To compare 3-year event-free survival
Description
definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To evaluate and compare OS between the two arms
Time Frame
3 years
Title
To evaluate and compare the ORR and CR rate
Time Frame
after completion of treatment
Title
To evaluate and compare disease-free survival (DFS)
Time Frame
3 years
Title
To evaluate treatment-failure pattern
Time Frame
3 years
Title
Number of Participants with Adverse Events in each arm
Time Frame
3 years
Title
To assess patient-reported outcomes (PROs) in both arms
Time Frame
3 years
Title
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Histologically confirmed CD20-positive Diffuse Large B-cell Lymphoma (DLBCL), NOS
Immunostains for CD20, CD5, CD3, CD10, MUM-1, BCL-6, BCL-2 and Ki-67 and the in situ hybridization for Epstein-Barr virus are recommended for diagnosis of DLBCL, NOS.
No prior treatment for DLBCL
Stage I or contiguous II disease (Involvement of two adjacent lymph node regions or organ involvement with regional lymph nodes)
Performance status: ECOG 0-2.
Age ≥ 18 years
Cardiac ejection fraction ≥ 45% as measured by MUGA or 2D ECHO without clinically significant abnormalities
Adequate renal function: serum creatinine level < 2 mg/dL
Adequate liver functions
Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
Life expectancy >= 6 months
A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
Exclusion Criteria:
Other subtypes NHL than CD20 (+) DLBCL, NOS
Transformed DLBCL from follicular lymphoma or other indolent lymphomas
Bulky disease ( longest diameter >=10 cm)
Previous treatment for DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion
CNS involvement by lymphoma or any evidence of spinal cord compression.
Primary Central Nervous System (CNS) DLBCL
Primary testicular lymphoma
Primary breast lymphoma
Patients with a known history of HIV seropositivity or HCV (+). (Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.)
Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
Pregnant or lactating women
Men who are not surgically sterile and women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions
Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
History of significant neurological or psychiatric disorders including dementia or seizures
Active uncontrolled infection (viral, bacterial or fungal infection)
Other serious medical illnesses
Known hypersensitivity to any of the study drugs or its ingredients
Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
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R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
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