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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00147121
First received: September 5, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma

Condition Intervention Phase
Lymphoma, B-Cell
Drug: Rituximab + Standard CHOP
Drug: Rituximab + Bi-weekly CHOP
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • CR rate (phase II) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • PFS (phase III) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ORR, PFS, OS, Safety (phase II) [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
  • OS, Safety (phase III) [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: September 2002
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Rituximab+Standard CHOP
Drug: Rituximab + Standard CHOP
Rituximab + Standard CHOP
Experimental: 2
Rituximab+bi-Weekly CHOP
Drug: Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP

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

Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147121

Locations
Japan
Aichi Medical University
Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi, Japan, 480-1195
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Nagoya City University Hospital
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi, Japan, 467-8601
Nagoya University School of Medicine
Nagoya,Showa-ku, Tsurumai-cho,65, Aichi, Japan, 466-8550
Nagoya Daini Red Cross Hospital
Nagoya,Showa-ku,Myoken-cho,2-9, Aichi, Japan, 466-8650
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan, 460-0001
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan, 010-8543
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan, 791-0295
University of Fukui Hospital
Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, Japan, 910-1193
School of Medicine,Fukuoka University
Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, Japan, 814-0180
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
National Hospital Organization Kyusyu Medical Center
FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, Japan, 810-0065
University of Occupational and Environmental Health
Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, Japan, 807-0804
Ohta Nishinouchi Hospital
Kohriyama,Nishinouchi,2-5-20, Fukushima, Japan, 963-8022
Gunma University
Maebashi,Showa,3-39-15, Gunma, Japan, 371-8511
Sapporo Hokuyu Hospital
Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, Japan, 003-0006
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
Kanazawa Medical University
Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa, Japan, 920-0265
Imamura Bun-in Hospital
Kagoshima,Kamoikeshinmachi,11-23, Kagoshima, Japan, 890-0064
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, Japan, 259-1193
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, Japan, 241-0811
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, Japan, 860-8556
NHO Kumamoto Medical Center
Kumamoto,Ninomaru,1-5, Kumamoto, Japan, 860-0008
Kyoto Prefectural University of Medicine
Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, Japan, 602-0841
Mie University School of Medicine
Tsu,Edobashi,2-174, Mie, Japan, 514-8507
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Nagasaki University Hospital
Nagasaki,Sakamoto,1-7-1, Nagasaki, Japan, 852-8501
Nagasaki Medical Center
Oomura,Kubara,2-1001-1, Nagasaki, Japan, 856-8562
Sasebo City General Hospital
Sasebo,Hirasemachi,9-3, Nagasaki, Japan, 857-8511
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Oita Prefectural Hospital
Oita,Bunyo,476, Oita, Japan, 870-8511
Faculty of Medicine,University of Ryukyus
Nakagami,Nishihara,Uehara,207, Okinawa, Japan, 903-0125
Faculty of Medicine, Saga University
Saga,Nabeshima,5-1-1, Saga, Japan, 849-8501
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
Shiga Medical Center for Adults
Moriyama,Moriyama,5-4-30, Shiga, Japan, 524-8524
Hamamatsu University School of Medicine
Hamamatsu,Handayama,1-20-1, Shizuoka, Japan, 431-3192
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
National Cancer Center Hospital
Chuo-kum,Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
Jikei University,Daisan Hospital
Komae,Izumihoncho,4-11-1, Tokyo, Japan, 201-8601
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
Tokyo Medical University
Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan, 160-0023
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Kensei Tobinai, M.D.,Ph.D. National Cancer Center Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00147121     History of Changes
Other Study ID Numbers: JCOG0203  C000000033 
Study First Received: September 5, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
Rituximab
CHOP
Bi-weekly
low-grade B-cell lymphoma
advanced stage
follicular lymphoma
G-CSF
Untreated stage III/IV low-grade B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016