Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
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)
2 other identifiers
interventional
300
1 country
45
Brief Summary
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2002
Longer than P75 for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 5, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedSeptember 22, 2016
September 1, 2016
7.4 years
September 5, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
CR rate (phase II)
during the study conduct
PFS (phase III)
during the study conduct
Secondary Outcomes (2)
ORR, PFS, OS, Safety (phase II)
during the study conduct
OS, Safety (phase III)
during the study conduct
Study Arms (2)
1
ACTIVE COMPARATORRituximab+Standard CHOP
2
EXPERIMENTALRituximab+bi-Weekly CHOP
Interventions
Eligibility Criteria
You may qualify if:
- 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
- \<=age\<=69
- ECOG PS 0-2
- 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
You may not qualify if:
- CNS involvement
- Glaucoma
- DM treated by insulin
- Uncontrollable HT
- AP, AMI
- Positive HBs antigen
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (45)
Aichi Medical University
Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi-ken, 480-1195, Japan
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Nagoya City University Hospital
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, 467-8601, Japan
Nagoya University School of Medicine
Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, 466-8550, Japan
Nagoya Daini Red Cross Hospital
Nagoya,Showa-ku,Myoken-cho,2-9, Aichi-ken, 466-8650, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, 460-0001, Japan
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, 010-8543, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan
Ehime University Hospital
Shitsukawa,Toon, Ehime, 791-0295, Japan
University of Fukui Hospital
Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, 910-1193, Japan
School of Medicine,Fukuoka University
Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, 814-0180, Japan
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395, Japan
National Hospital Organization Kyusyu Medical Center
FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, 810-0065, Japan
University of Occupational and Environmental Health
Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, 807-0804, Japan
Ohta Nishinouchi Hospital
Kohriyama,Nishinouchi,2-5-20, Fukushima, 963-8022, Japan
Gunma University
Maebashi,Showa,3-39-15, Gunma, 371-8511, Japan
Sapporo Hokuyu Hospital
Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, 003-0006, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804, Japan
Kanazawa Medical University
Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa-ken, 920-0265, Japan
Imamura Bun-in Hospital
Kagoshima,Kamoikeshinmachi,11-23, Kagoshima-ken, 890-0064, Japan
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520, Japan
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, 259-1193, Japan
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, 241-0811, Japan
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, 860-8556, Japan
NHO Kumamoto Medical Center
Kumamoto,Ninomaru,1-5, Kumamoto, 860-0008, Japan
Kyoto Prefectural University of Medicine
Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, 602-0841, Japan
Mie University School of Medicine
Tsu,Edobashi,2-174, Mie-ken, 514-8507, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki,Sakamoto,1-7-1, Nagasaki, 852-8501, Japan
Nagasaki Medical Center
Oomura,Kubara,2-1001-1, Nagasaki, 856-8562, Japan
Sasebo City General Hospital
Sasebo,Hirasemachi,9-3, Nagasaki, 857-8511, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan
Oita Prefectural Hospital
Oita,Bunyo,476, Oita Prefecture, 870-8511, Japan
Faculty of Medicine,University of Ryukyus
Nakagami,Nishihara,Uehara,207, Okinawa, 903-0125, Japan
Faculty of Medicine, Saga University
Saga,Nabeshima,5-1-1, Saga-ken, 849-8501, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan
Shiga Medical Center for Adults
Moriyama,Moriyama,5-4-30, Shiga, 524-8524, Japan
Hamamatsu University School of Medicine
Hamamatsu,Handayama,1-20-1, Shizuoka, 431-3192, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677, Japan
National Cancer Center Hospital
Chuo-kum,Tsukiji, 5-1-1, Tokyo, 104-0045, Japan
Jikei University,Daisan Hospital
Komae,Izumihoncho,4-11-1, Tokyo, 201-8601, Japan
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461, Japan
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611, Japan
Tokyo Medical University
Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, 160-0023, Japan
Related Publications (3)
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.
PMID: 37996986DERIVEDWatanabe 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.
PMID: 30389034DERIVEDWatanabe 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.
PMID: 21931035DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kensei Tobinai, M.D.,Ph.D.
National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
September 5, 2005
First Posted
September 7, 2005
Study Start
September 1, 2002
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
September 22, 2016
Record last verified: 2016-09