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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008535
Receipt No. 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 2018/04/19

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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
Last 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
Email rnishika@saitama-med.ac.jp

Public contact
1st 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/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 06 Day
Date of IRB
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
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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