Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Tracking Information
First Submitted Date ICMJE	March 8, 2004
First Posted Date ICMJE	March 10, 2004
Last Update Posted Date	September 24, 2012
Study Start Date ICMJE	January 2004
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 8, 2006)	Complete response as assessed by Cheson criteria
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00079261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 8, 2006)	Toxicity as assessed by CTC 2.0; Proportion of courses given as scheduled; Freedom from treatment failure as assessed by Cheson criteria
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Official Title ICMJE	Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
Brief Summary	RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Detailed Description	OBJECTIVES: Primary; Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone with vs without gemcitabine. Secondary; Compare the safety profile of these regimens in these patients.; Compare the feasibility of these regimens, defined as the proportion of courses given as scheduled, in these patients.; Compare freedom from treatment failure in patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, International Prognostic Index score (0-2 vs 3-5), and histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.; Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.; Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease. Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8 courses). Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for this study within 2 years.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lymphoma; Small Intestine Cancer
Intervention ICMJE	Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: prednisone; Drug: vincristine sulfate
Study Arms	Not Provided
Publications *	Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 20, 2012)	25
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes: Diffuse large B large cell lymphoma (including all clinical and morphologic variants) Grade 3 follicular lymphoma Extranodal T/NK cell lymphoma, nasal type Enteropathy-type T cell lymphoma Hepato-splenic T cell lymphoma Peripheral T cell lymphoma, unspecified Angioimmunoblastic lymphoma Anaplastic large cell lymphoma, systemic type; Stage II-IV disease; At least 1 site of measurable disease (e.g., lymph node or lymph node mass); The following subtypes are not allowed: Mantle cell lymphoma Burkitt's lymphoma Precursor B or T cell lymphoma Primary cutaneous B or T cell lymphoma; No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age; 18 to 70 Performance status; Not specified Life expectancy; Not specified Hematopoietic; WBC > 3,000/mm^3; Neutrophil count > 1,000/mm^3; Platelet count > 100,000/mm^3 Hepatic; Bilirubin < 2.5 times normal (unless due to lymphoma); ALT and AST < 2.5 times normal (unless due to lymphoma) Renal; Creatinine < 2.0 mg/dL Cardiovascular; No severe cardiac disease that would preclude study participation or limit life expectancy Pulmonary; FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma); No severe pulmonary disease that would preclude study participation or limit life expectancy Other; Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix; No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy; No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy; No concurrent monoclonal antibodies Chemotherapy; No other concurrent chemotherapy Endocrine therapy; Not specified Radiotherapy; No prior radiotherapy; No concurrent radiotherapy Surgery; Not specified Other; No prior cytotoxic agents; No prior treatment for NHL; No other concurrent anticancer therapy; No other concurrent investigational drugs
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Croatia, Egypt, France, Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00079261
Other Study ID Numbers ICMJE	EORTC-20021; EORTC-20021
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor ICMJE	European Organisation for Research and Treatment of Cancer - EORTC
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Igor Aurer, MD, PhD University Hospital Rebro
PRS Account	European Organisation for Research and Treatment of Cancer - EORTC
Verification Date	September 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP