NCT01357733

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

March 2, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

5.7 years

First QC Date

May 13, 2011

Last Update Submit

August 4, 2022

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Diffuse, Large B-Cell, Lymphoma18F FluorodeoxyglucoseRadionuclide-Emission Computed Tomography

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles

    Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients

    baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP

  • Change from baseline in summed SULpeak after 1 cycle

    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

    baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP

Secondary Outcomes (3)

  • 2 year disease free survival

    up to 2 years after initial diagnosis

  • Qualitative response

    after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP

  • Quantitative response

    after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP

Study Arms (1)

Interim FDG PET/CT

OTHER

Single arm study with diagnostic imaging study as the intervention.

Other: Early interim FDG PET/CT after 1 cycle of R-CHOP

Interventions

Early interim FDG PET/CT after 1 cycle of R-CHOPOTHER

FDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP

Interim FDG PET/CT

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related Publications (3)

  • Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.

    PMID: 19403881BACKGROUND

  • Michallet AS, Trotman J, Tychyj-Pinel C. Role of early PET in the management of diffuse large B-cell lymphoma. Curr Opin Oncol. 2010 Sep;22(5):414-8. doi: 10.1097/CCO.0b013e32833d5905.

    PMID: 20683268BACKGROUND

  • Zelenetz AD, Abramson JS, Advani RH, Andreadis CB, Byrd JC, Czuczman MS, Fayad L, Forero A, Glenn MJ, Gockerman JP, Gordon LI, Harris NL, Hoppe RT, Horwitz SM, Kaminski MS, Kim YH, Lacasce AS, Mughal TI, Nademanee A, Porcu P, Press O, Prosnitz L, Reddy N, Smith MR, Sokol L, Swinnen L, Vose JM, Wierda WG, Yahalom J, Yunus F. NCCN Clinical Practice Guidelines in Oncology: non-Hodgkin's lymphomas. J Natl Compr Canc Netw. 2010 Mar;8(3):288-334. doi: 10.6004/jnccn.2010.0021. No abstract available.

    PMID: 20202462BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Seok-Goo Cho, MD, PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Joo Hyun O, MD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Department of Radiology

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 23, 2011

Study Start

March 2, 2012

Primary Completion

November 29, 2017

Study Completion

March 31, 2023

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

KR(1)