UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008535 |
|---|---|
| Receipt number | R000010031 |
| Scientific Title | Phase III Study of High-dose Methotrexate and Whole Brain Radiotherapy With or Without Concomitant and Adjuvant Temozolomide in Patients with Primary CNS Lymphoma (JCOG1114C, PCNSL-TMZ-P3) |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2021/01/05 16:16:16 |
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Basic information
Public title
Phase III Study of High-dose Methotrexate and Whole Brain Radiotherapy With or Without Concomitant and Adjuvant Temozolomide in Patients with Primary CNS Lymphoma (JCOG1114C, PCNSL-TMZ-P3)
Acronym
Phase III study of standard chemoradiotherapy with or without temozolomide in newly-diagnosed PCNSL
(JCOG1114C, PCNSL-TMZ-P3)
Scientific Title
Phase III Study of High-dose Methotrexate and Whole Brain Radiotherapy With or Without Concomitant and Adjuvant Temozolomide in Patients with Primary CNS Lymphoma (JCOG1114C, PCNSL-TMZ-P3)
Scientific Title:Acronym
Phase III study of standard chemoradiotherapy with or without temozolomide in newly-diagnosed PCNSL
(JCOG1114C, PCNSL-TMZ-P3)
Region
| Japan |
Condition
Condition
newly-diagnosed primary Central Nervous System (CNS) lymphoma
Classification by specialty
| Hematology and clinical oncology | Neurology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the superiority in overall survival of the addition of concomitant and adjuvant temozolomide (TMZ) chemotherapy over the standard treatment of high-dose methotrexate (HD-MTX) and radiotherapy in patients with primary CNS lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Response rate after HD-MTX, response rate after radiotherapy, complete response rate after HD-MTX, complete response rate after radiotherapy, progression-free survival, adverse events, early deaths, treatment-related deaths, Grade 4 non-hematologic adverse events, proportion of MMSE non-worsening, completion of HD-MTX, completion of radiotherapy, cycles of adjuvant TMZ chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:HD-MTX + Radiotherapy
Interventions/Control_2
B:HD-MTX + Radiotherapy + Concomitant and Adjuvant TMZ Chemotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*First registration (after surgery)
1)Histologically proven diffuse large B-cell lymphoma.
2)Lymphoma originating from the central nervous system except for the spinal cord. Existence of intraocular lymphoma is eligible.
3)Both solitary/multiple lesions are eligible.
4)Both measurable/immeasurable lesions are eligible
5)No evidence of lymphomatous meningitis confirmed by cerebrospinal fluid cytology or brain/whole spine MRI.
6)No evidence of lymphomatosis cerebri.
7)Postoperative date between 3 and 35 days.
8)ECOG PS 0-2, or PS 3 caused by neurological deficits associated with tumors.
Following cases are also eligible: PS 0-2 ameliorated by administration of corticosteroids, glycerol, mannitol or corticosteroids.
9)No prior treatment with chemotherapy or cranial radiotherapy as treatment for other malignancies and malignant lymphoma.
10)No evidence of lymphoma outside the CNS and the eyes confirmed by CT scanning with contrast enhancement of the chest, abdomen and the pelvis.
11)Adequate organ function.
12)Written informed consent.
*Second registration (after HD-MTX treatment)
1)At least one cycle of HD-MTX treatment administered
2)Between 10 and 21 days after the HD-MTX treatment.
3)ECOG performance status: 0-2 or 3 due to neurological deficits.
4)Brain MRI with gadolinium enhancement after HD-MTX was implemented.
5)CSF cytology negative
6)No evidence of lymphoma outside the CNS and the eyes
7)Ocular lesions are evaluated by fundus examination under mydriasis and slit lump examination.
8)No infection or appetite loss of grade 3 or higher. No evidence of pneumonitis of grade 2 or higher.
9)No fever of 38C or higher suggestive of infection.
10)Adequate organ function.
Key exclusion criteria
First registration (after surgery)
1)Concurrent malignancies (concurrent double cancer or metachronous cancer within 5 years) excluding basal cell carcinoma of the skin or cervical carcinoma in situ.
2)Concurrent infectious diseases necessitate systemic treatment.
3)HIV antibody positive.
4)HBs antigen positive
5)HCV antibody positive
6)Patients with immune deficiency syndrome such as AIDS, X-linked agammaglobulinemia, chronic granulomatous diseases or Wiskott-Aldrich Syndrome.
7)Organ transplant patients.
8)Body temperature more than 38C.
9)Infectious meningitis necessitating treatment.
10)Pregnant or lactating patients.
11)Concurrent psychiatric problems.
12)Those under treatment with continual use of insulin or with the complication of uncontrolled diabetes mellitus.
13)Evidence of unstable angina (onset within 3 weeks or deteriorating symptoms) or history of cardiac infarction within 6 months.
14)Concurrent pulmonary fibrosis or interstitial pneumonia.
15)Patients for whom both gadolinium and iodine contrast media cannot be applied because of allergy.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Nishikawa |
Organization
International Medical Center, Saitama Medical University
Division name
Department of Neurosurgery/Neuro-Oncology
Zip code
Address
1397-1, Yamane, Hidaka-city, Saitama, Japan
TEL
042-984-4111
rnishika@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Mishima |
Organization
JCOG1114C Coordinating Office
Division name
Department of Neurosurgery/Neuro-Oncology , International Medical Center, Saitama Medical University
Zip code
Address
1397-1, Yamane, Hidaka-city, Saitama, Japan
TEL
042-984-4111
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
中村記念病院（北海道）
弘前大学医学部附属病院（青森県）
岩手医科大学（岩手県）
東北大学病院（宮城県）
山形大学医学部（山形県）
筑波大学医学医療系（茨城県）
獨協医科大学病院（栃木県）
埼玉医科大学国際医療センター（埼玉県）
千葉大学医学部（千葉県）
国立がん研究センター中央病院（東京都）
日本大学医学部附属板橋病院（東京都）
杏林大学医学部（東京都）
慶應義塾大学病院（東京都）
東京医科歯科大学（東京都）
東京大学医学部（東京都）
北里大学医学部（神奈川県）
新潟大学医歯学総合病院（新潟県）
静岡県立静岡がんセンター（静岡県）
名古屋大学医学部（愛知県）
藤田保健衛生大学（愛知県）
京都大学医学部附属病院（京都府）
大阪大学医学部（大阪府）
大阪国際がんセンター（大阪府）
関西医科大学附属病院（大阪府）
神戸大学医学部（兵庫県）
岡山大学病院（岡山県）
広島大学病院（広島県）
愛媛大学医学部附属病院（愛媛県）
九州大学病院（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Advanced Medical Care B
Management information
Registered date
| 2012 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010031
