Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients
|ClinicalTrials.gov Identifier: NCT01357733|
Recruitment Status : Unknown
Verified April 2012 by Sung Hoon Kim, The Catholic University of Korea.
Recruitment status was: Recruiting
First Posted : May 23, 2011
Last Update Posted : April 10, 2012
Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) scan at the time of initial staging. The patients will be diagnosed and undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.
After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers from nadir (usually 13 to 16 days after) following the administration of first cycle of R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT study will not impact patient management, except in rare case where newly developed lesion is found and biopsy confirmed.
The same PET/CT system and analysis software will be used for all scans from baseline to surveillance for all patients enrolled in this study.
After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with newly developed lesion will receive different chemotherapy regimen, while patients with stable disease, partial metabolic response or complete metabolic response will continue to receive 3 more cycles of R-CHOP.
After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for response assessment. Selected patients with persistent disease or very bulky tumor volume on initial staging images will receive additional radiation therapy.
The patients will be followed up every 3 months for 2 years from beginning of therapy. Physical examination and lab studies will be done usually every 3 months. Imaging studies will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted when different schedule is applied for surveillance.
The end points are changes in FDG uptake measurements between the baseline and early interim FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response assessment following completion of 6 cycles of R-CHOP with or without radiation therapy assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid Tumors (PERCIST) guideline; and the 2 year disease free survival.
|Condition or disease||Intervention/treatment|
|Lymphoma, Large B-Cell, Diffuse||Other: Early interim FDG PET/CT after 1 cycle of R-CHOP|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2016|
Interim FDG PET/CT
Single arm study with diagnostic imaging study as the intervention.
Other: Early interim FDG PET/CT after 1 cycle of R-CHOP
FDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP
- Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles [ Time Frame: baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP ]Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients
- Change from baseline in summed SULpeak after 1 cycle [ Time Frame: baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP ]Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and early interim FDG PET/CT after 1 cycle of R-CHOP in DLBCL patients
- 2 year disease free survival [ Time Frame: up to 2 years after initial diagnosis ]Patients considered to have 2 year disease free survival will be those with complete response after 6 cycles of R-CHOP or isolated persistent disease treated by radiation therapy, AND continuous disease free state for 2 years from the start of therapy (reference standard "success"). All other patients will be considered to not have achieved 2 year disease free survival.
- Qualitative response [ Time Frame: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP ]Response according to IWC+PET criteria with qualitative visual analysis of FDG PET/CT using mediastinum as the background reference.
- Quantitative response [ Time Frame: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP ]Response according to PERCIST criteria with change in summed SULpeak in the FDG PET/CT as the background reference.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357733
|Contact: Seok-Goo Cho, MD, PhDfirstname.lastname@example.org|
|Contact: Joo Hyun O, MDemail@example.com|
|Korea, Republic of|
|The Catholic University of Korea Seoul St. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 137701|
|Contact: Seok-Goo Cho, MD, PhD 82-2-2258-1551 firstname.lastname@example.org|
|Contact: Joo Hyun O, MD 443-642-7573 email@example.com|
|Sub-Investigator: Joo Hyun O, MD|
|Sub-Investigator: Eun Ji Han, MD|
|Sub-Investigator: Seung-Eun Jung, MD, PhD|
|Sub-Investigator: Hyelim Park, MD|
|Sub-Investigator: Woo Hee Choi, MD|
|Sub-Investigator: Hyun Soo Choi, MD|
|Principal Investigator: Seok-Goo Cho, MD, PhD|
|Principal Investigator: Sung Hoon Kim, MD, PhD|
|Principal Investigator:||Seok-Goo Cho, MD, PhD||The Catholic University of Korea|
|Principal Investigator:||Sung Hoon Kim, Md, PhD||The Catholic University of Korea|