Completed

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

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What is being tested

CHOP regimen

+ cyclophosphamide
+ doxorubicin hydrochloride
Drug
Who is being recruted

Lymphoma

+ Small Intestine Cancer
From 18 to 70 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004

See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleGem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma 
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
Small Intestine Cancer
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 6 locations
Suspended
U.Z. GasthuisbergLeuven, BelgiumSee the location
Suspended
Algemeen Ziekenhuis Sint-AugustinusWilrijk, Belgium
Suspended
University Hospital RebroZagreb, Croatia
Suspended
National Cancer Institute - CairoCairo, Egypt
Completed6 Study Centers