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Lymphoma, B-CellPhase 2/3NCT00147121

Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

A Phase 2/3 study testing Rituximab + Standard CHOP and Rituximab + Bi-weekly CHOP in people with Lymphoma, B-Cell, run by Haruhiko Fukuda at 45 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma Read more about this study

Who is it for?
Ages 20 to 69 years
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
Rituximab + Standard CHOP and Rituximab + Bi-weekly CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
45 sitesJapan
Study dates
Sep 2002to Feb 2010
Phase
Phase 2/3
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 20 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
  • CD20-positive
  • Ann Arbor CS III or IV
  • Lymphoma cell count in PB≦10,000/mm3
  • 20<=age<=69
  • ECOG PS 0-2
Show all 10Show fewer
  • Bidimensionally measurable disease >1.5cm in a single dimension by CT scans
  • No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
  • Normal BM, hepatic, renal, cardiac, and pulmonary function
  • Written informed consent

Who cannot join

  • CNS involvement
  • Glaucoma
  • DM treated by insulin
  • Uncontrollable HT
  • AP, AMI
  • Positive HBs antigen
Show all 15Show fewer
  • seropositive to HCV
  • seropositive to HIV
  • Interstitial pneumonitis, pulmonary fibrosis, or emphysema
  • Severe infection
  • Liver cirrhosis
  • Double cancer
  • Pregnant or lactating
  • Patients who desire auto PBST after CR
  • Patients treated with major tranquilizer or antidepressant

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Japan45 sites

  • Aichi Medical University

    Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi-ken, 480-1195

  • Akita University School of Medicine

    Akita,Hondo,1-1-1, Akita, 010-8543

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677

  • Chiba Cancer Center Hospital

    Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-kum,Tsukiji, 5-1-1, Tokyo, 104-0045

  • School of Medicine,Fukuoka University

    Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, 814-0180

  • National Kyushu Cancer Center

    Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395

  • National Hospital Organization Kyusyu Medical Center

    FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, 810-0065

  • Hamamatsu University School of Medicine

    Hamamatsu,Handayama,1-20-1, Shizuoka, 431-3192

  • Tokai University School of Medicine

    Isehara,Shimokasuya,143, Kanagawa, 259-1193

  • Imamura Bun-in Hospital

    Kagoshima,Kamoikeshinmachi,11-23, Kagoshima-ken, 890-0064

  • Kagoshima University,Faculty of Medicine

    Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520

  • Kanazawa Medical University

    Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa-ken, 920-0265

  • National Cancer Center Hospital East

    Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577

  • Saitama Cancer Center

    Kita-adachi,Ina,Komuro,818, Saitama, 362-0806

  • University of Occupational and Environmental Health

    Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, 807-0804

  • Ohta Nishinouchi Hospital

    Kohriyama,Nishinouchi,2-5-20, Fukushima, 963-8022

  • Jikei University,Daisan Hospital

    Komae,Izumihoncho,4-11-1, Tokyo, 201-8601

  • Kumamoto University Medical School

    Kumamoto,Honjo,1-1-1, Kumamoto, 860-8556

  • NHO Kumamoto Medical Center

    Kumamoto,Ninomaru,1-5, Kumamoto, 860-0008

  • Kyoto Prefectural University of Medicine

    Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, 602-0841

  • Gunma University

    Maebashi,Showa,3-39-15, Gunma, 371-8511

  • Jikei University Hospital

    Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461

  • Kyorin University School of Medicine

    Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611

  • Shiga Medical Center for Adults

    Moriyama,Moriyama,5-4-30, Shiga, 524-8524

  • Nagasaki University Hospital

    Nagasaki,Sakamoto,1-7-1, Nagasaki, 852-8501

  • Aichi Cancer Center Hospital

    Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681

  • Nagoya City University Hospital

    Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, 467-8601

  • Nagoya Medical Center

    Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, 460-0001

  • Nagoya University School of Medicine

    Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, 466-8550

  • Nagoya Daini Red Cross Hospital

    Nagoya,Showa-ku,Myoken-cho,2-9, Aichi-ken, 466-8650

  • Faculty of Medicine,University of Ryukyus

    Nakagami,Nishihara,Uehara,207, Okinawa, 903-0125

  • Niigata Cancer Center Hospital

    Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566

  • Oita Prefectural Hospital

    Oita,Bunyo,476, Oita Prefecture, 870-8511

  • Nagasaki Medical Center

    Oomura,Kubara,2-1001-1, Nagasaki, 856-8562

  • Faculty of Medicine, Saga University

    Saga,Nabeshima,5-1-1, Saga-ken, 849-8501

  • Sapporo Hokuyu Hospital

    Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, 003-0006

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804

  • Sasebo City General Hospital

    Sasebo,Hirasemachi,9-3, Nagasaki, 857-8511

  • Tohoku University Hospital

    Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574

  • Tokyo Medical University

    Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, 160-0023

  • Ehime University Hospital

    Shitsukawa,Toon, Ehime, 791-0295

  • Mie University School of Medicine

    Tsu,Edobashi,2-174, Mie-ken, 514-8507

  • St.Marianna University School of Medicine,Yokohama City Seibu Hospital

    Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, 241-0811

  • University of Fukui Hospital

    Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, 910-1193

Other trials in Japan

About this study

Official title: Rituximab + Standard CHOP (R･S-CHOP) vs Rituximab+ Bi-weekly CHOP (R･Bi-CHOP) RCT(Phase II/III) for Stage III/IV Low-grade B-cell Lymphoma (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma

Read the detailed description

Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.

Being tested
Rituximab + Standard CHOP, Rituximab + Bi-weekly CHOP
Keywords
Rituximab, CHOP, Bi-weekly, low-grade B-cell lymphoma, advanced stage, follicular lymphoma, G-CSF, Untreated stage III/IV low-grade B-cell lymphoma
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Follicular

What participants receive

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

  • Rituximab + Standard CHOPDrug

    Rituximab + Standard CHOP

  • Rituximab + Bi-weekly CHOPDrug

    Rituximab + Bi-weekly CHOP

Study groups in NCT00147121
Study groupRoleWhat they receive
1Active comparatorRituximab+Standard CHOP
Receives: Drug: Rituximab + Standard CHOP
2ExperimentalRituximab+bi-Weekly CHOP
Receives: Drug: Rituximab + Bi-weekly CHOP

What is being measured

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

  1. CR rate (phase II)

    Measured: during the study conduct

  2. PFS (phase III)

    Measured: during the study conduct

Secondary outcomes (2)

  1. ORR, PFS, OS, Safety (phase II)

    Measured: during the study conduct

  2. OS, Safety (phase III)

    Measured: during the study conduct

Timeline

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

  1. First posted7 Sep 2005 (estimated)
  2. Study startSep 2002
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147121
Sponsor's protocol ID
JCOG0203
Other IDs
C000000033
Status last verified
Sep 2016
First submitted
5 Sep 2005
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Watanabe T, Tobinai K, Wakabayashi M, Maruyama D, Yamamoto K, Kubota N, Shimada K, Asagoe K, Yamaguchi M, Ando K, Ogura M, Kuroda J, Suehiro Y, Matsuno Y, Tsukasaki K, Nagai H. R-CHOP treatment for patients with advanced follicular lymphoma: Over 15-year follow-up of JCOG0203. Br J Haematol. 2024 Mar;204(3):849-860. doi: 10.1111/bjh.19213. Epub 2023 Nov 23.

    PubMed 37996986

  • Watanabe T, Tobinai K, Wakabayashi M, Morishima Y, Kobayashi H, Kinoshita T, Suzuki T, Yamaguchi M, Ando K, Ogura M, Taniwaki M, Uike N, Yoshino T, Nawano S, Terauchi T, Hotta T, Nagai H, Tsukasaki K; JCOG0203 Collaborators. Outcomes after R-CHOP in patients with newly diagnosed advanced follicular lymphoma: a 10-year follow-up analysis of the JCOG0203 trial. Lancet Haematol. 2018 Nov;5(11):e520-e531. doi: 10.1016/S2352-3026(18)30155-8.

    PubMed 30389034

  • Watanabe T, Tobinai K, Shibata T, Tsukasaki K, Morishima Y, Maseki N, Kinoshita T, Suzuki T, Yamaguchi M, Ando K, Ogura M, Taniwaki M, Uike N, Takeuchi K, Nawano S, Terauchi T, Hotta T. Phase II/III study of R-CHOP-21 versus R-CHOP-14 for untreated indolent B-cell non-Hodgkin's lymphoma: JCOG 0203 trial. J Clin Oncol. 2011 Oct 20;29(30):3990-8. doi: 10.1200/JCO.2011.34.8508. Epub 2011 Sep 19.

    PubMed 21931035

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rituximab + Standard CHOP and Rituximab + Bi-weekly CHOP in people with Lymphoma, B-Cell, run by Haruhiko Fukuda at 45 sites 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

CR rate (phase II) (time frame: during the study conduct). The study lists 2 primary outcomes in all. 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 NCT00147121, which also lists 3 linked publications.

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 22 Sep 2016.

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