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

Primary Purpose

Lymphoma, B-Cell

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Rituximab + Standard CHOP
Rituximab + Bi-weekly CHOP
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Rituximab, CHOP, Bi-weekly, low-grade B-cell lymphoma, advanced stage, follicular lymphoma, G-CSF, Untreated stage III/IV low-grade B-cell lymphoma

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 20<=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 Exclusion Criteria: 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

Sites / Locations

  • Aichi Medical University
  • Aichi Cancer Center Hospital
  • Nagoya City University Hospital
  • Nagoya University School of Medicine
  • Nagoya Daini Red Cross Hospital
  • Nagoya Medical Center
  • Akita University School of Medicine
  • Chiba Cancer Center Hospital
  • National Cancer Center Hospital East
  • Ehime University Hospital
  • University of Fukui Hospital
  • School of Medicine,Fukuoka University
  • National Kyushu Cancer Center
  • National Hospital Organization Kyusyu Medical Center
  • University of Occupational and Environmental Health
  • Ohta Nishinouchi Hospital
  • Gunma University
  • Sapporo Hokuyu Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Kanazawa Medical University
  • Imamura Bun-in Hospital
  • Kagoshima University,Faculty of Medicine
  • Tokai University School of Medicine
  • St.Marianna University School of Medicine,Yokohama City Seibu Hospital
  • Kumamoto University Medical School
  • NHO Kumamoto Medical Center
  • Kyoto Prefectural University of Medicine
  • Mie University School of Medicine
  • Tohoku University Hospital
  • Nagasaki University Hospital
  • Nagasaki Medical Center
  • Sasebo City General Hospital
  • Niigata Cancer Center Hospital
  • Oita Prefectural Hospital
  • Faculty of Medicine,University of Ryukyus
  • Faculty of Medicine, Saga University
  • Saitama Cancer Center
  • Shiga Medical Center for Adults
  • Hamamatsu University School of Medicine
  • Tokyo Metropolitan Komagome Hospital
  • National Cancer Center Hospital
  • Jikei University,Daisan Hospital
  • Jikei University Hospital
  • Kyorin University School of Medicine
  • Tokyo Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Rituximab+Standard CHOP

Rituximab+bi-Weekly CHOP

Outcomes

Primary Outcome Measures

CR rate (phase II)
PFS (phase III)

Secondary Outcome Measures

ORR, PFS, OS, Safety (phase II)
OS, Safety (phase III)

Full Information

First Posted
September 5, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00147121
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Rituximab+Standard CHOP
Arm Title
2
Arm Type
Experimental
Arm Description
Rituximab+bi-Weekly CHOP
Intervention Type
Drug
Intervention Name(s)
Rituximab + Standard CHOP
Intervention Description
Rituximab + Standard CHOP
Intervention Type
Drug
Intervention Name(s)
Rituximab + Bi-weekly CHOP
Intervention Description
Rituximab + Bi-weekly CHOP
Primary Outcome Measure Information:
Title
CR rate (phase II)
Time Frame
during the study conduct
Title
PFS (phase III)
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
ORR, PFS, OS, Safety (phase II)
Time Frame
during the study conduct
Title
OS, Safety (phase III)
Time Frame
during the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 20<=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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensei Tobinai, M.D.,Ph.D.
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Medical University
City
Aichi-gun,Nagakute,Yazako,Karimata,21
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan
Facility Name
Nagoya University School of Medicine
City
Nagoya,Showa-ku, Tsurumai-cho,65
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya,Showa-ku,Myoken-cho,2-9
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Nagoya Medical Center
City
Nagoya,Naka-ku,Sannomaru,4-1-1
State/Province
Aich
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Akita University School of Medicine
City
Akita,Hondo,1-1-1
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba Cancer Center Hospital
City
Chiba,Chuo-ku,Nitona-cho,666-2
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Ehime University Hospital
City
Shitsukawa,Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida-gun,Matsuoka,Shimoaizuki,23-3
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
School of Medicine,Fukuoka University
City
Fukuoka,Jonan-ku,Nanakuma,7-45-1
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka,Minami-ku,Notame,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
National Hospital Organization Kyusyu Medical Center
City
FukuokaChuo-ku,Jigyohama,1-8-1
State/Province
Fukuoka
ZIP/Postal Code
810-0065
Country
Japan
Facility Name
University of Occupational and Environmental Health
City
Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1
State/Province
Fukuoka
ZIP/Postal Code
807-0804
Country
Japan
Facility Name
Ohta Nishinouchi Hospital
City
Kohriyama,Nishinouchi,2-5-20
State/Province
Fukushima
ZIP/Postal Code
963-8022
Country
Japan
Facility Name
Gunma University
City
Maebashi,Showa,3-39-15
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Sapporo Hokuyu Hospital
City
Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kanazawa Medical University
City
Kahoku-gun,Uchinada-machi,Daigaku,1-1
State/Province
Ishikawa
ZIP/Postal Code
920-0265
Country
Japan
Facility Name
Imamura Bun-in Hospital
City
Kagoshima,Kamoikeshinmachi,11-23
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Kagoshima University,Faculty of Medicine
City
Kagoshima,Sakuragaoka,8-35-1
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Tokai University School of Medicine
City
Isehara,Shimokasuya,143
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
City
Yokohama,Asahi-ku,Yasashi-cho,1197-1
State/Province
Kanagawa
ZIP/Postal Code
241-0811
Country
Japan
Facility Name
Kumamoto University Medical School
City
Kumamoto,Honjo,1-1-1
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
NHO Kumamoto Medical Center
City
Kumamoto,Ninomaru,1-5
State/Province
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465
State/Province
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
Facility Name
Mie University School of Medicine
City
Tsu,Edobashi,2-174
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki,Sakamoto,1-7-1
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Nagasaki Medical Center
City
Oomura,Kubara,2-1001-1
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Sasebo City General Hospital
City
Sasebo,Hirasemachi,9-3
State/Province
Nagasaki
ZIP/Postal Code
857-8511
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Oita,Bunyo,476
State/Province
Oita
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
Faculty of Medicine,University of Ryukyus
City
Nakagami,Nishihara,Uehara,207
State/Province
Okinawa
ZIP/Postal Code
903-0125
Country
Japan
Facility Name
Faculty of Medicine, Saga University
City
Saga,Nabeshima,5-1-1
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shiga Medical Center for Adults
City
Moriyama,Moriyama,5-4-30
State/Province
Shiga
ZIP/Postal Code
524-8524
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu,Handayama,1-20-1
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku,Honkomagome,3-18-22
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-kum,Tsukiji, 5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Jikei University,Daisan Hospital
City
Komae,Izumihoncho,4-11-1
State/Province
Tokyo
ZIP/Postal Code
201-8601
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku,Nishishinbashi,3-25-8
State/Province
Tokyo
ZIP/Postal Code
105-8461
Country
Japan
Facility Name
Kyorin University School of Medicine
City
Mitaka,Shinkawa,6-20-2
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Medical University
City
Shinjuku-ku,Nishi-shinjuku,6-7-1
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30389034
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.
Results Reference
derived
PubMed Identifier
21931035
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

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