Rituximab+Standard CHOP vs Rituximab+bi-Weekly CHOP for Untreated Stage III/IV Low-Grade B-Cell Lymphoma (JCOG0203)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Japan Clinical Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00147121
First received: September 5, 2005
Last updated: February 2, 2009
Last verified: February 2009
  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
Estimated Study Completion Date: February 2010
Estimated 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
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
Nagoya City University Hospital
1,Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya, Aichi, Japan, 467-8601
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Nagoya Daini Red Cross Hospital
2-9,Myoken-cho,Showa-ku,Nagoya, Aichi, Japan, 466-8650
Aichi Medical University
21,Karimata,Yazako,Nagakute,Aichi-gun, Aichi, Japan, 480-1195
Nagoya University School of Medicine
65 Tsurumai-cho,Showa-ku,Nagoya, Aichi, Japan, 466-8550
Nagoya Medical Center
4-1-1,Sannomaru,Naka-ku,Nagoya, Aich, Japan, 460-0001
Akita University School of Medicine
1-1-1,Hondo,Akita, Akita, Japan, 010-8543
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan, 791-0295
University of Fukui Hospital
23-3,Shimoaizuki,Matsuoka,Yoshida-gun, Fukui, Japan, 910-1193
University of Occupational and Environmental Health
1-1,Iseigaoka,Yahatanishi-ku,Kitakyushu, Fukuoka, Japan, 807-0804
National Hospital Organization Kyusyu Medical Center
1-8-1,Jigyohama,Chuo-ku,Fukuoka, Fukuoka, Japan, 810-0065
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan, 811-1395
School of Medicine,Fukuoka University
7-45-1,Nanakuma,Jonan-ku,Fukuoka, Fukuoka, Japan, 814-0180
Ohta Nishinouchi Hospital
2-5-20,Nishinouchi,Kohriyama, Fukushima, Japan, 963-8022
Gunma University
3-39-15,Showa,Maebashi, Gunma, Japan, 371-8511
National Hospital Organization Hokkaido Cancer Center
4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido, Japan, 003-0804
Sapporo Hokuyu Hospital
6-5-1,Higashi-sapporo6,Shiroishi-ku,Sapporo, Hokkaido, Japan, 003-0006
Kanazawa Medical University
1-1,Daigaku,Uchinada-machi,Kahoku-gun, Ishikawa, Japan, 920-0265
Imamura Bun-in Hospital
11-23,Kamoikeshinmachi,Kagoshima, Kagoshima, Japan, 890-0064
Kagoshima University,Faculty of Medicine
8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan, 890-8520
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
1197-1,Yasashi-cho,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0811
Tokai University School of Medicine
143,Shimokasuya,Isehara, Kanagawa, Japan, 259-1193
Kumamoto University Medical School
1-1-1,Honjo,Kumamoto, Kumamoto, Japan, 860-8556
NHO Kumamoto Medical Center
1-5,Ninomaru,Kumamoto, Kumamoto, Japan, 860-0008
Kyoto Prefectural University of Medicine
465,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto, Kyoto, Japan, 602-0841
Mie University School of Medicine
2-174,Edobashi,Tsu, Mie, Japan, 514-8507
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-8574
Nagasaki University Hospital
1-7-1,Sakamoto,Nagasaki, Nagasaki, Japan, 852-8501
Nagasaki Medical Center
2-1001-1,Kubara,Oomura, Nagasaki, Japan, 856-8562
Sasebo City General Hospital
9-3,Hirasemachi,Sasebo, Nagasaki, Japan, 857-8511
Niigata Cancer Center Hospital
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566
Oita Prefectural Hospital
476 Bunyo,Oita, Oita, Japan, 870-8511
Faculty of Medicine,University of Ryukyus
207,Uehara,Nishihara,Nakagami, Okinawa, Japan, 903-0125
Faculty of Medicine, Saga University
5-1-1,Nabeshima,Saga, Saga, Japan, 849-8501
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
Shiga Medical Center for Adults
5-4-30,Moriyama,Moriyama, Shiga, Japan, 524-8524
Hamamatsu University School of Medicine
1-20-1,Handayama,Hamamatsu, Shizuoka, Japan, 431-3192
Tokyo Metropolitan Komagome Hospital
3-18-22,Honkomagome,Bunkyo-ku, Tokyo, Japan, 113-8677
Jikei University Hospital
3-25-8,Nishishinbashi,Minato-ku, Tokyo, Japan, 105-8461
Jikei University,Daisan Hospital
4-11-1,Izumihoncho,Komae, Tokyo, Japan, 201-8601
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Kyorin University School of Medicine
6-20-2,Shinkawa,Mitaka, Tokyo, Japan, 181-8611
Tokyo Medical University
6-7-1,Nishi-shinjuku,Shinjuku-ku, Tokyo, Japan, 160-0023
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Kensei Tobinai, M.D.,Ph.D. National Cancer Center Hospital
  More Information

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: February 2, 2009
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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 01, 2014