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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025187
Receipt No. R000028684
Scientific Title Phase III study of watchful waiting versus rituximab as first-line treatment in patients with low tumor burden of advanced stage follicular lymphoma(JCOG1411, FLORA study)
Date of disclosure of the study information 2016/12/08
Last modified on 2016/12/08

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Basic information
Public title Phase III study of watchful waiting versus rituximab as first-line treatment in patients with low tumor burden of advanced stage follicular lymphoma(JCOG1411, FLORA study)
Acronym Phase III study of watchful waiting versus rituximab as first-line treatment in patients with low tumor burden of advanced stage follicular lymphoma(JCOG1411, FLORA study)
Scientific Title Phase III study of watchful waiting versus rituximab as first-line treatment in patients with low tumor burden of advanced stage follicular lymphoma(JCOG1411, FLORA study)
Scientific Title:Acronym Phase III study of watchful waiting versus rituximab as first-line treatment in patients with low tumor burden of advanced stage follicular lymphoma(JCOG1411, FLORA study)
Region
Japan

Condition
Condition Follicular lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of rituximab as first-line treatment versus watchful waiting in patients with low tumor burden of advanced stage follicular lymphoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Event-free survival
Key secondary outcomes cytotoxic therapy-free survival, histological transformation-free survival, overall survival, progression-free survival, response proportion, adverse events, severe adverse events.

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: Watchful waiting. When at least one of the following (i) to (iii) is fulfilled, 1 cycle of rituximab at 375 mg/m2 on day1, 8, 15, and 22 is administered. (i) more than 5 cm and less than 7 cm in the maximum tumor diameter (ii) three nodal sites of 3 cm (iii) moderate pleural and peritoneal effusion.
Interventions/Control_2 B: Rituximab as first-line treatment. 1 cycle of rituximab at 375 mg/m2 on day1, 8, 15, and 22. When at least one of the following (i) to (iii) is fulfilled, 1 cycle of rituximab is administered. (i) more than 5cm and less than 7cm in the maximum tumor diameter (ii) three nodal sites of 3 cm (iii) moderate pleural and peritoneal effusion.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Follicular lymphoma (Grade1, 2 and 3A) with CD20 positive.
2) Ann Arbor CS III and IV diagnosed by CT and bone marrow examination within 56 days before entry
3) The following (i) to (vi) are fulfilled by physical findings and CT within 56 days before entry
(i) Largest nodal or extra nodal mass less than 5cm
(ii) Two or less nodal sites with a diameter of 3cm or more
(iii) The absence of B symptoms
(iv) Spleen size is less than 16cm by CT
(v) No significant serous effusions
(vi) No critical organ compression
4) Aged 20 to 80 years old
5) ECOG performance status (PS) of 0 or 1
6) Bidimensionally measurable disease >1.5cm in a single dimention by CT
7) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
8) Patients with sufficient organ functions
9) Written informed consent
Key exclusion criteria 1. Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years.
2. Infectious disease requiring systemic treatment.
3. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
4. Severe psychological disorder.
5. Receiving continuous systemic corticosteroid or immunosuppressant treatment.
6. Insulin-dependent or uncontrollable diabetes mellitus
7. Uncontrollable hypertension
8. Unstable angina pectoris, or history of myocardial infarction within six months.
9. HBs-Ag positive or HCV-Ab positive
10. HBs-Ab positive or HBc-Ab positive with HBV DNA levels of 2.1 log copies/mL or more
11. Positive HIV antibody
12. Uncontrollable glaucoma
Target sample size 290

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Ishizawa
Organization Yamagata University Faculty of Medicine
Division name Department of Hematology and Cell Therapy
Zip code
Address 2-2-2 Iidanishi, Yamagata city, Yamagata Prefecture, 990-9585 Japan
TEL 023-628-5516
Email kishizaw@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Fukuhara
Organization JCOG1411Coordinating Office
Division name Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Prefecture, 980-8574 Japan
TEL 022-717-7165
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
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 国立病院機構北海道がんセンター(北海道)
札幌北楡病院(北海道)
東北大学病院(宮城県)
秋田大学医学部(秋田県)
山形大学医学部(山形県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学第三病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
NTT東日本関東病院(東京都)
東海大学医学部(神奈川県)
金沢医科大学(石川県)
福井大学医学部附属病院(福井県)
浜松医科大学(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋大学医学部(愛知県)
名古屋市立大学病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知医科大学附属病院(愛知県)
豊田厚生病院(愛知県)
三重大学医学部(三重県)
滋賀県立成人病センター(滋賀県)
京都府立医科大学(京都府)
兵庫県立がんセンター(兵庫県)
岡山医療センター(岡山県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
愛媛大学医学部附属病院(愛媛県)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
国立病院機構九州医療センター(福岡県)
産業医科大学(福岡県)
佐賀大学医学部(佐賀県)
国立病院機構長崎医療センター(長崎県)
佐世保市総合医療センター(長崎県)
長崎大学病院(長崎県)
日本赤十字社長崎原爆病院(長崎県)
熊本大学医学部(熊本県)
国立病院機構熊本医療センター(熊本県)
大分県立病院(大分県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
今村病院分院(鹿児島県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 08 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
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 08 Day
Last follow-up date
2027 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 08 Day
Last modified on
2016 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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