Clinical trial NCT00147121: Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lymphoma, B-Cell
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
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: CR rate (phase II)
timeFrame: during the study conduct
measure: PFS (phase III)
timeFrame: during the study conduct
Secondary outcomes:
measure: ORR, PFS, OS, Safety (phase II)
timeFrame: during the study conduct
measure: OS, Safety (phase III)
timeFrame: during the study conduct
Other outcomes:
Locations:
city: Aichi-gun,Nagakute,Yazako,Karimata,21
country: Japan
facility: Aichi Medical University
state: Aichi
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya,Showa-ku, Tsurumai-cho,65
country: Japan
facility: Nagoya University School of Medicine
state: Aichi
city: Nagoya,Showa-ku,Myoken-cho,2-9
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Nagoya,Naka-ku,Sannomaru,4-1-1
country: Japan
facility: Nagoya Medical Center
state: Aich
city: Akita,Hondo,1-1-1
country: Japan
facility: Akita University School of Medicine
state: Akita
city: Chiba,Chuo-ku,Nitona-cho,666-2
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Shitsukawa,Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Yoshida-gun,Matsuoka,Shimoaizuki,23-3
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Fukuoka,Jonan-ku,Nanakuma,7-45-1
country: Japan
facility: School of Medicine,Fukuoka University
state: Fukuoka
city: Fukuoka,Minami-ku,Notame,3-1-1
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: FukuokaChuo-ku,Jigyohama,1-8-1
country: Japan
facility: National Hospital Organization Kyusyu Medical Center
state: Fukuoka
city: Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
city: Kohriyama,Nishinouchi,2-5-20
country: Japan
facility: Ohta Nishinouchi Hospital
state: Fukushima
city: Maebashi,Showa,3-39-15
country: Japan
facility: Gunma University
state: Gunma
city: Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1
country: Japan
facility: Sapporo Hokuyu Hospital
state: Hokkaido
city: Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kahoku-gun,Uchinada-machi,Daigaku,1-1
country: Japan
facility: Kanazawa Medical University
state: Ishikawa
city: Kagoshima,Kamoikeshinmachi,11-23
country: Japan
facility: Imamura Bun-in Hospital
state: Kagoshima
city: Kagoshima,Sakuragaoka,8-35-1
country: Japan
facility: Kagoshima University,Faculty of Medicine
state: Kagoshima
city: Isehara,Shimokasuya,143
country: Japan
facility: Tokai University School of Medicine
state: Kanagawa
city: Yokohama,Asahi-ku,Yasashi-cho,1197-1
country: Japan
facility: St.Marianna University School of Medicine,Yokohama City Seibu Hospital
state: Kanagawa
city: Kumamoto,Honjo,1-1-1
country: Japan
facility: Kumamoto University Medical School
state: Kumamoto
city: Kumamoto,Ninomaru,1-5
country: Japan
facility: NHO Kumamoto Medical Center
state: Kumamoto
city: Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Tsu,Edobashi,2-174
country: Japan
facility: Mie University School of Medicine
state: Mie
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagasaki,Sakamoto,1-7-1
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Oomura,Kubara,2-1001-1
country: Japan
facility: Nagasaki Medical Center
state: Nagasaki
city: Sasebo,Hirasemachi,9-3
country: Japan
facility: Sasebo City General Hospital
state: Nagasaki
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Oita,Bunyo,476
country: Japan
facility: Oita Prefectural Hospital
state: Oita
city: Nakagami,Nishihara,Uehara,207
country: Japan
facility: Faculty of Medicine,University of Ryukyus
state: Okinawa
city: Saga,Nabeshima,5-1-1
country: Japan
facility: Faculty of Medicine, Saga University
state: Saga
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Moriyama,Moriyama,5-4-30
country: Japan
facility: Shiga Medical Center for Adults
state: Shiga
city: Hamamatsu,Handayama,1-20-1
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Bunkyo-ku,Honkomagome,3-18-22
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Chuo-kum,Tsukiji, 5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Komae,Izumihoncho,4-11-1
country: Japan
facility: Jikei University,Daisan Hospital
state: Tokyo
city: Minato-ku,Nishishinbashi,3-25-8
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Mitaka,Shinkawa,6-20-2
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku,Nishi-shinjuku,6-7-1
country: Japan
facility: Tokyo Medical University
state: Tokyo
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, M.D.,Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.