UMIN-CTR Clinical Trial

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

Follicular lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Ishizawa
Middle name
Last name	Kenichi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Hematology and Cell Therapy

Zip code

990-9585

Address

2-2-2 Iidanishi, Yamagata city, Yamagata Prefecture, 990-9585 Japan

TEL

023-628-5516

Email

kishizaw@med.id.yamagata-u.ac.jp

Name of contact person

1st name	Fukuhara
Middle name
Last name	Noriko

Organization

JCOG1411Coordinating Office

Division name

Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine

Zip code

980-8574

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

12

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

10

Month

07

Day

Date of IRB

2016

Year

11

Month

10

Day

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 related information

Registered date

2016

Year

12

Month

08

Day

Last modified on

2023

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028684