Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Sung Hoon Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01357733
First received: May 13, 2011
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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 Intervention
Lymphoma, Large B-Cell, Diffuse
Other: Early interim FDG PET/CT after 1 cycle of R-CHOP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 2 year disease free survival [ Time Frame: up to 2 years after initial diagnosis ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Response according to PERCIST criteria with change in summed SULpeak in the FDG PET/CT as the background reference.


Estimated Enrollment: 130
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD20+ diffuse large B cell lymphoma confirmed
  • Therapy naïve for lymphoma
  • 19 years or older
  • Written informed consent

Exclusion Criteria:

  • Cannot understand informed consent
  • Age under 19 years old
  • Previous chemotherapy or radiation therapy for lymphoma
  • Known pregnancy or urine/serum hCG (+)
  • Unable to lie down still on back for about 30 minutes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357733

Contacts
Contact: Seok-Goo Cho, MD, PhD 82-2-2258-1511 chosg@catholic.ac.kr
Contact: Joo Hyun O, MD 443-642-7573 ojoohyun@gmail.com

Locations
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    chosg@catholic.ac.kr   
Contact: Joo Hyun O, MD    443-642-7573    ojoohyun@gmail.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         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Seok-Goo Cho, MD, PhD The Catholic University of Korea
Principal Investigator: Sung Hoon Kim, Md, PhD The Catholic University of Korea
  More Information

Publications:
Responsible Party: Sung Hoon Kim, Chairman of Department of Radiology, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01357733     History of Changes
Other Study ID Numbers: KC11EISI0293
Study First Received: May 13, 2011
Last Updated: April 9, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
Diffuse, Large B-Cell, Lymphoma
18F Fluorodeoxyglucose
Radionuclide-Emission Computed Tomography

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014