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Non-Hodgkin's LymphomaPhase 3NCT00133302

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

A Phase 3 study testing Standard CHOP and Bi-CHOP (dose intensified CHOP) in people with Non-Hodgkin's Lymphoma, run by Japan Clinical Oncology Group at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 15 to 69 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Standard CHOP and Bi-CHOP (dose intensified CHOP)
How many people
450 participants
Where
1 siteJapan
Study dates
Feb 1999to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 69 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Central nervous system (CNS) invasion
  • HIV positive
  • Hepatitis B surface antigen (HBs-Ag) positive
  • Hepatitis C virus antibody (HCV-Ab) positive

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Tokai University

    Isehara, Kanagawa, 259-1193

Other trials in Japan

About this study

Official title: Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

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).

Read the 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).

Being tested
Standard CHOP, Bi-CHOP (dose intensified CHOP)
Keywords
Non-Hodgkin's lymphoma, intermediate-grade lymphoma, high-grade lymphoma, CHOP protocol, granulocyte-colony stimulating factor
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard CHOPDrug

  • Bi-CHOP (dose intensified CHOP)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

Secondary outcomes (3)

  1. Overall survival

  2. Complete remission rate

  3. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2005 (estimated)
  2. Study startFeb 1999
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133302
Sponsor's protocol ID
JCOG9809
Other IDs
C000000036
Status last verified
Aug 2006
First submitted
22 Aug 2005
Last updated
18 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 21196441

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard CHOP and Bi-CHOP (dose intensified CHOP) in people with Non-Hodgkin's Lymphoma, run by Japan Clinical Oncology Group at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00133302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2007; AzTrials last refreshed its copy on 7 Nov 2026.

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