Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly … (NCT00678327) | Clinical Trial Compass
CompletedPhase 3
Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma
United Kingdom1,202 participantsStarted 2008-08-29
Plain-language summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
Who can participate
Age range18 Years – 100 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following criteria:
* Meets current WHO classification criteria (i.e., nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte-depleted)
* Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following:
* Bulk mediastinal disease, defined as maximal transverse diameter of mass \> 0.33 of the internal thoracic diameter at D5/6 interspace on routine chest x-ray
* Disease outside the mediastinum and lymph node or lymph node mass \> 10 cm in diameter
* More than two sites of disease
* Other poor-risk features that require treatment with full course combination chemotherapy
* Newly diagnosed disease
* No CNS or meningeal involvement by lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy \> 3 months
* ANC \> 1,500/mm\^3 (unless there is bone marrow infiltration by lymphoma)
* Platelet count \> 100,000/mm\^3 (unless there is bone marrow infiltration by lymphoma)
* Creatinine \< 150% of upper limit of normal (ULN)
* Bilirubin \< 2.0 times ULN (unless attributed to lymphoma)
* Transaminases \< 2.5 times ULN (unless attributed to lymphoma)
* LVEF ≥ 50% (in patients with a significant history of ischemic heart disease or hypertension)
* Diffusion capacity within 25% of normal predicted value by lung function testing
* Not pregnant or nursing
* Negative pregnancy tes…