Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)

Asan Medical Center1 site in 1 countryFebruary 4, 2014

ConditionsDiffuse Large B-cell Lymphoma

InterventionsR-CHOP Radiotherapy

DrugsR-CHOP

Overview

Phase: Phase 3
Intervention: R-CHOP
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: Asan Medical Center
Locations: 1
Primary Endpoint: To compare 3-year event-free survival
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 4, 2014

End Date

January 2020

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Cheolwon Suh

Professor

Asan Medical Center

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-
•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

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

Arms & Interventions

Total 6 cycles of R-CHOP

Intervention: R-CHOP

Total 3 cycles of R-CHOP + RT

Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions)

Intervention: R-CHOP

Total 3 cycles of R-CHOP + RT

Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions)

Intervention: Radiotherapy

Outcomes

Primary Outcomes

To compare 3-year event-free survival

Time Frame: 3 years

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 Outcomes

To evaluate and compare disease-free survival (DFS)(3 years)
Number of Participants with Adverse Events in each arm(3 years)
To assess patient-reported outcomes (PROs) in both arms(3 years)
To evaluate and compare the ORR and CR rate(after completion of treatment)
To evaluate and compare OS between the two arms(3 years)
To evaluate treatment-failure pattern(3 years)
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS(3 years)