UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019868 |
|---|---|
| Receipt number | R000022939 |
| Scientific Title | Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study) |
| Date of disclosure of the study information | 2015/11/20 |
| Last modified on | 2021/01/05 16:05:56 |
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Basic information
Public title
Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Acronym
Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Scientific Title
Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Scientific Title:Acronym
Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Region
| Japan |
Condition
Condition
Previously untreated advanced stage Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this trial is to confirm the utility of interim PET (after 2 cycles of ABVD as induction phase)-guided treatment strategy (followed by additional 4 cycles of ABVD if interim PET-negative or 6 cycles of escalated BEACOPP if interim PET-positive) for previously untreated advanced stage Hodgkin lymphoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
2-year progressin-free survival among all eligible patients and among inteim PET-positive patients (Co-primary endpoints)
Key secondary outcomes
overall survival, event-free survival, complete response rate, incidence of adverse events, incidence of severe adverse events, incidence of secondary malignancy, incidence of per-protocol in terms of interim PET
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After 2 cycles of ABVD for all patients, interim PET is performed.
Interim PET-negative patients receive additional 4 cycles of ABVD (every 4 weeks); doxorubicin 25mg/m2, div, day1and 15; bleomycin 9mg/m2 (max 15mg/body), div, day1 and 15; vinblastine 6mg/m2 (max 10mg/body), iv, day1 and 15; dacarbazine 375mg/m2, div, day1 and 15.
Interim PET-positive patients receive 6 cycles of escalated BEACOPP (every 3 weeks); bleomycin 10mg/m2 (max 15mg/body) div day8; etoposide 200mg/m2 div day1-3; doxorubicin 35mg/m2 div day1; cyclophosphamide 1250mg/m2 div day1; vincristine 1.4mg/m2 (max 2mg/body) iv day8; procarbazine 100mg/m2 po day1-7; prednisolone 40mg/m2 po day1-14; G-CSF sc day4-.
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed as classical Hodgkin lymphoma according to WHO classification 2008.
2) Clinical stage III or IV, or clinical stage IIB with bulky mediastinal lesion or continuously invasive lesion to extranodal tissues.
3) No central nervous system involvement
4) Aged 20 to 60 years old at enrollment
5) ECOG Performance status: 0-2
6) Having measuralble lesion (fulfill the 3 following criteria)
(1) lymph node or extranodal disease diagnosed as Hodgkin lymphoma by imaging, histopathological or cytopathological method.
(2) measurable lesion by CT scan (transverse imaging with bidimensional measurements)
(3) longest transverse diameter for lesions of 1.5 cm or more.
7) No previous anti-cancer treatment (chemotherapy and/or radiation) except for hormone therapy
8) Meet all of the following:
(1) absolute neutrophil count: no less than 1,000/mm3
(2) platelet count: no less than 100,000/mm3
(3) total bilirubin: 2.0 mg/dL or below
(4) AST(GOT) : no more than 150 U/L
(5) ALT(GPT) : no more than 150 U/L
(6) serum creatinine: 1.6 mg/dL or below (male), 1.2 mg/dL or below (female)
(7) fasting blood glucose: 150 mg/dL or below
(8) PaO2 (room air): at least 70 torr
9) ECG: neither ischemic change nor arrhythmia requiring medical intervention
10) Cardiac ejection fraction: at least 50%
11) Written informed consent by the patient
Key exclusion criteria
1) Synchronous or metachronous malignancy
2) Active infection requiring systemic treatment
3) Pregnant or nursing women
4) Psychiatric disease
5) Continuous systemic treatment with steroids or other immunosuppressive drugs
6) Insulin-dependent or uncontrollable diabetes mellitus
7) Unstable angina pectoris, or history of myocardial infarction within six months
8) Seropositive for HBsAg or anti-HCV antibody
9) Seropositive for anti-HIV antibody or unexamined
10) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema on chest CT
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Nagai |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Division of Hematology
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, 460-0001 Japan
TEL
052-951-1111
nagaih@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Kusumoto |
Organization
JCOG1305 Coordinating Office
Division name
Division of Hematology and Oncology, Nagoya City University Hospital
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601 Japan
TEL
052-853-8738
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
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
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）
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）
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）
佐世保市立総合病院（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
| 2015 | Year | 11 | Month | 20 | 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
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | 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=R000022939
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