Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL
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| First Received Date ICMJE | August 3, 2010 | ||||
| Last Updated Date | January 22, 2013 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ] Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relpase of DLBCL |
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| Original Primary Outcome Measures ICMJE |
Disease-free survival at 2 year [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01279902 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL | ||||
| Official Title ICMJE | Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma | ||||
| Brief Summary | Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diffuse Large B-cell Lymphoma With Ann-Arbor Stage I or II | ||||
| Intervention ICMJE | Drug: 3 Cycles of Rituximab plus CHOP Immunochemotherapy
The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5). |
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| Study Arm (s) | Experimental: 3 Cycles of R-CHOP
3 Cycles of R-CHOP immunochemotherapy
Intervention: Drug: 3 Cycles of Rituximab plus CHOP Immunochemotherapy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 23 | ||||
| Estimated Completion Date | October 2015 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01279902 | ||||
| Other Study ID Numbers ICMJE | AMC_NHL01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Cheolwon Suh, Asan Medical Center | ||||
| Study Sponsor ICMJE | Asan Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asan Medical Center | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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