Study of Standard CHOP Versus Biweekly CHOP in Aggressive... | NCT00133302

Studies
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

NCT00133302

Sponsor

Japan Clinical Oncology Group

Status

Terminated

Last Update Posted

Jan 18, 2007Estimated

Enrollment

450

Phase

Phase 3

Conditions

Non-Hodgkin's Lymphoma

Interventions

Standard CHOP
Bi-CHOP (dose intensified CHOP)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
C000000036

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1999

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Aug 22, 2005

First Submission Date that Met QC Criteria

Aug 22, 2005

First Posted Date

Aug 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2007

Last Update Posted Date

Jan 18, 2007Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Description Module

Brief Summary

The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).

Detailed Description

The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450

Measure	Description	Time Frame
Progression free survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)
Ann Arbor stage: II, III, IV
No prior chemotherapy or radiotherapy
Age: 15 to 69
Performance status (PS): 0, 1, 2
WBC >= 3,000 /mm3, ANC >= 1,200 /mm3, Platelet >= 75,000 /mm3
GOT/GPT <= 5 x Normal Upper Limit, T-Bil <= 2.0 mg/dL
Creatinine <= 2.0 mg/dL
Normal ECG, Ejection Fraction >= 50%
PaO2 >= 65 mmHg
Written informed consent

Exclusion Criteria:

Uncontrollable diabetes mellitus
Severe complication (infection, heart failure, renal failure, liver failure, etc)
Anamnesis of heart disease
Acute or chronic hepatitis, liver cirrhosis and portal hypertension
Synchronous or metachronous malignancy
Severe pulmonary dysfunction
Central nervous system (CNS) invasion
HIV positive
Hepatitis B surface antigen (HBs-Ag) positive
Hepatitis C virus antibody (HCV-Ab) positive

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

69 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Tomomitsu Hotta, MD, PhD	Tokai University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Tokai University		Isehara	Kanagawa	259-1193	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21196441	Derived	Ohmachi K, Tobinai K, Kobayashi Y, Itoh K, Nakata M, Shibata T, Morishima Y, Ogura M, Suzuki T, Ueda R, Aikawa K, Nakamura S, Fukuda H, Shimoyama M, Hotta T; members of the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). Phase III trial of CHOP-21 versus CHOP-14 for aggressive non-Hodgkin's lymphoma: final results of the Japan Clinical Oncology Group Study, JCOG 9809. Ann Oncol. 2011 Jun;22(6):1382-1391. doi: 10.1093/annonc/mdq619. Epub 2010 Dec 31.

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Name	Type	Description	Arm Group Labels	Other Names
Standard CHOP	Drug
Bi-CHOP (dose intensified CHOP)	Drug