Clinical trial NCT02054559: R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
Keywords: localized
diffuse large B-cell lymphoma
R-CHOP chemotherapy
radiotherapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: To compare 3-year event-free survival
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate and compare OS between the two arms
timeFrame: 3 years
measure: To evaluate and compare the ORR and CR rate
timeFrame: after completion of treatment
measure: To evaluate and compare disease-free survival (DFS)
timeFrame: 3 years
measure: To evaluate treatment-failure pattern
timeFrame: 3 years
measure: Number of Participants with Adverse Events in each arm
timeFrame: 3 years
measure: To assess patient-reported outcomes (PROs) in both arms
timeFrame: 3 years
measure: A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: