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
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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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2002-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Rituximab+Standard CHOP
Rituximab + Standard CHOP
Rituximab + Standard CHOP
2
Rituximab+bi-Weekly CHOP
Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP
Interventions
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Rituximab + Standard CHOP
Rituximab + Standard CHOP
Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
69 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
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
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, Japan
Nagoya University School of Medicine
Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, Japan
Nagoya Daini Red Cross Hospital
Nagoya,Showa-ku,Myoken-cho,2-9, Aichi-ken, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan
University of Fukui Hospital
Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, Japan
School of Medicine,Fukuoka University
Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, Japan
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
National Hospital Organization Kyusyu Medical Center
FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, Japan
University of Occupational and Environmental Health
Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, Japan
Ohta Nishinouchi Hospital
Kohriyama,Nishinouchi,2-5-20, Fukushima, Japan
Gunma University
Maebashi,Showa,3-39-15, Gunma, Japan
Sapporo Hokuyu Hospital
Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Kanazawa Medical University
Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa-ken, Japan
Imamura Bun-in Hospital
Kagoshima,Kamoikeshinmachi,11-23, Kagoshima-ken, Japan
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, Japan
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, Japan
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, Japan
NHO Kumamoto Medical Center
Kumamoto,Ninomaru,1-5, Kumamoto, Japan
Kyoto Prefectural University of Medicine
Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, Japan
Mie University School of Medicine
Tsu,Edobashi,2-174, Mie-ken, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Nagasaki University Hospital
Nagasaki,Sakamoto,1-7-1, Nagasaki, Japan
Nagasaki Medical Center
Oomura,Kubara,2-1001-1, Nagasaki, Japan
Sasebo City General Hospital
Sasebo,Hirasemachi,9-3, Nagasaki, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Oita Prefectural Hospital
Oita,Bunyo,476, Oita Prefecture, Japan
Faculty of Medicine,University of Ryukyus
Nakagami,Nishihara,Uehara,207, Okinawa, Japan
Faculty of Medicine, Saga University
Saga,Nabeshima,5-1-1, Saga-ken, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan
Shiga Medical Center for Adults
Moriyama,Moriyama,5-4-30, Shiga, Japan
Hamamatsu University School of Medicine
Hamamatsu,Handayama,1-20-1, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
National Cancer Center Hospital
Chuo-kum,Tsukiji, 5-1-1, Tokyo, Japan
Jikei University,Daisan Hospital
Komae,Izumihoncho,4-11-1, Tokyo, Japan
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Tokyo Medical University
Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan
Countries
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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.
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.
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.
Related Links
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Related Info
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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