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
Recruitment status was Active, not recruiting
Sponsor:
Japan Clinical Oncology Group
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
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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:
- 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
Contacts and Locations
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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013