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S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Bu çalışma, sınırlı evre diffüz büyük B hücreli lenfoma (diffuse large B-cell lymphoma) olan hastalarda PET taraması sonuçlarına göre yönlendirilen tedaviyi (R-CHOP rejimi ve gerektiğinde ışın tedavisi) değerlendirmiştir. Çalışmaya biyopsi ile tanısı doğrulanmış, evre I veya II hastalığı olan hastalar alınmıştır. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
DISEASE CHARACTERISTICS: * Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL) * Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group * Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections * Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible * Patients must have non-bulky stage I or II disease by Ann Arbor classification * This staging excludes FDG-PET evaluation * Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible * Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration * Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol * If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable * Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration * Patients may have either measurable or evaluable limited-stage DLBCL * Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible * If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187) * All measurable disease must be assessed within 28 days prior to registration * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration * Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome) * Patients must not be pregnant or nursing * Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period * Patients must not be known to be HIV-positive * No other prior malignancy is allowed except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma