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

NCT ID: NCT00147121

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rituximab+Standard CHOP

Group Type ACTIVE_COMPARATOR

Rituximab + Standard CHOP

Intervention Type DRUG

Rituximab + Standard CHOP

2

Rituximab+bi-Weekly CHOP

Group Type EXPERIMENTAL

Rituximab + Bi-weekly CHOP

Intervention Type DRUG

Rituximab + Bi-weekly CHOP

Interventions

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Rituximab + Standard CHOP

Rituximab + Standard CHOP

Intervention Type DRUG

Rituximab + Bi-weekly CHOP

Rituximab + Bi-weekly CHOP

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
2. CD20-positive
3. Ann Arbor CS III or IV
4. Lymphoma cell count in PB≦10,000/mm3
5. 20\<=age\<=69
6. ECOG PS 0-2
7. Bidimensionally measurable disease \>1.5cm in a single dimension by CT scans
8. No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
9. Normal BM, hepatic, renal, cardiac, and pulmonary function
10. Written informed consent

Exclusion Criteria

1. CNS involvement
2. Glaucoma
3. DM treated by insulin
4. Uncontrollable HT
5. AP, AMI
6. Positive HBs antigen
7. seropositive to HCV
8. seropositive to HIV
9. Interstitial pneumonitis, pulmonary fibrosis, or emphysema
10. Severe infection
11. Liver cirrhosis
12. Double cancer
13. Pregnant or lactating
14. Patients who desire auto PBST after CR
15. Patients treated with major tranquilizer or antidepressant
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role collaborator

Haruhiko Fukuda

OTHER

Sponsor Role lead

Responsible Party

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Haruhiko Fukuda

JCOG Data Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kensei Tobinai, M.D.,Ph.D.

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

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Aichi Medical University

Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi-ken, Japan

Site Status

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Site Status

Nagoya City University Hospital

Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, Japan

Site Status

Nagoya University School of Medicine

Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, Japan

Site Status

Nagoya Daini Red Cross Hospital

Nagoya,Showa-ku,Myoken-cho,2-9, Aichi-ken, Japan

Site Status

Nagoya Medical Center

Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan

Site Status

Akita University School of Medicine

Akita,Hondo,1-1-1, Akita, Japan

Site Status

Chiba Cancer Center Hospital

Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

Site Status

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Site Status

Ehime University Hospital

Shitsukawa,Toon, Ehime, Japan

Site Status

University of Fukui Hospital

Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, Japan

Site Status

School of Medicine,Fukuoka University

Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, Japan

Site Status

National Kyushu Cancer Center

Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan

Site Status

National Hospital Organization Kyusyu Medical Center

FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, Japan

Site Status

University of Occupational and Environmental Health

Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, Japan

Site Status

Ohta Nishinouchi Hospital

Kohriyama,Nishinouchi,2-5-20, Fukushima, Japan

Site Status

Gunma University

Maebashi,Showa,3-39-15, Gunma, Japan

Site Status

Sapporo Hokuyu Hospital

Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan

Site Status

Kanazawa Medical University

Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa-ken, Japan

Site Status

Imamura Bun-in Hospital

Kagoshima,Kamoikeshinmachi,11-23, Kagoshima-ken, Japan

Site Status

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan

Site Status

Tokai University School of Medicine

Isehara,Shimokasuya,143, Kanagawa, Japan

Site Status

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

Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, Japan

Site Status

Kumamoto University Medical School

Kumamoto,Honjo,1-1-1, Kumamoto, Japan

Site Status

NHO Kumamoto Medical Center

Kumamoto,Ninomaru,1-5, Kumamoto, Japan

Site Status

Kyoto Prefectural University of Medicine

Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, Japan

Site Status

Mie University School of Medicine

Tsu,Edobashi,2-174, Mie-ken, Japan

Site Status

Tohoku University Hospital

Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan

Site Status

Nagasaki University Hospital

Nagasaki,Sakamoto,1-7-1, Nagasaki, Japan

Site Status

Nagasaki Medical Center

Oomura,Kubara,2-1001-1, Nagasaki, Japan

Site Status

Sasebo City General Hospital

Sasebo,Hirasemachi,9-3, Nagasaki, Japan

Site Status

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Site Status

Oita Prefectural Hospital

Oita,Bunyo,476, Oita Prefecture, Japan

Site Status

Faculty of Medicine,University of Ryukyus

Nakagami,Nishihara,Uehara,207, Okinawa, Japan

Site Status

Faculty of Medicine, Saga University

Saga,Nabeshima,5-1-1, Saga-ken, Japan

Site Status

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, Japan

Site Status

Shiga Medical Center for Adults

Moriyama,Moriyama,5-4-30, Shiga, Japan

Site Status

Hamamatsu University School of Medicine

Hamamatsu,Handayama,1-20-1, Shizuoka, Japan

Site Status

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan

Site Status

National Cancer Center Hospital

Chuo-kum,Tsukiji, 5-1-1, Tokyo, Japan

Site Status

Jikei University,Daisan Hospital

Komae,Izumihoncho,4-11-1, Tokyo, Japan

Site Status

Jikei University Hospital

Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan

Site Status

Kyorin University School of Medicine

Mitaka,Shinkawa,6-20-2, Tokyo, Japan

Site Status

Tokyo Medical University

Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 37996986 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30389034 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21931035 (View on PubMed)

Related Links

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Other Identifiers

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C000000033

Identifier Type: -

Identifier Source: secondary_id

JCOG0203

Identifier Type: -

Identifier Source: org_study_id

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