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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010386
Receipt No. R000012145
Scientific Title Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer
Date of disclosure of the study information 2013/04/01
Last modified on 2013/04/01

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Basic information
Public title Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer
Acronym Randomized phase II of adjuvant immunotherapy using alpha-GalCer-pulsed dendritic cells in completely resected stage II-IIIA non-small cell lung cancer (RADCLC)
Scientific Title Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer
Scientific Title:Acronym Randomized phase II of adjuvant immunotherapy using alpha-GalCer-pulsed dendritic cells in completely resected stage II-IIIA non-small cell lung cancer (RADCLC)
Region
Japan

Condition
Condition stage II-IIIA non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy of adjuvant immunotherapy with alpha-GalCel pulsed dendritic cells in patients with completely resected stage II or IIIA non-small cell lung cancer followed by adjuvant chemotherapy with cisplatin and vinorelbine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes disease free survival at 2 years
Key secondary outcomes NKT-specific immune response
safety
overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
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 intravenous administration of alpha-GalCel pulsed dendritic cells on day7, 14, 49 and 56
Interventions/Control_2 no treatment with alpha-GalCel pulsed dendritic cells
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients for whom non-small cell lung cancer is confirmed histologically
2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node
3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.)
4) The pathological stage is IIA, IIB, IIIA.
5) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old.
6) no recurrence at the time of enrollment
7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1.
8) Trial treatment can be started within 4 to 16 weeks after 3-4 cycles of adjuvant chemotherapy with cisplatin and vinorelbine.
9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.)
*Neutrophil count >=3,000/mm3
*Platelet count >=75,000/mm3
*Hemoglobin concentration>=9 g/dL
*Serum creatinine <=1.5 mg/dL
*Total bilirubin <=2.0 mg/dL
*AST/ALT <=2.0 X ULN of normal values in each institution
*SpO2 >=93%
10) NKT cells are detected at least 10 cells in 1 ml of peripheral blood.
11) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.
Key exclusion criteria 1) Serious concomitant disease including severe infectious disease or malnutrition.
2) Postoperative pleural effusion or ascites or cardiac effusion which need to be controlled.
3) The patient who have simultaneous malignancy or who have metachronous malignancy within 5 years-disease free interval.
4) Concurrent corticosteroid therapy
5)Autoimmune disease
6) History of hepatitis
7) Positive response to HIV, hepatitis C virus or human T cell lymphotrophic virus antibodies or those with HBs antigen.
8) Severe cardiac disease(NYHA class III or IV) or severe pulmonary disease (greater than Hugh-Jones Classification III)
9) History of hyper-reactivity to albmin
10) Pregnancy or lactation
11) Contraindication to apheresis (angina, greater than atrioventricular block 2 degree, WPW syndrome, complete left bundle branch block, systolic blood pressure with 90 Torr or greater than 170 Torr)
12) The patients have been judged to be inappropriate to participate in this study by principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukito Ichinose
Organization National Hospital Organization Kyushu Cancer Center
Division name Clnical Research Institute
Zip code
Address 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan
TEL 092-541-3231
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Takenoyama
Organization National Hospital Organization Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan
TEL 092-541-3231
Homepage URL
Email

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
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 国立病院機構九州がんセンター(福岡)、国立病院機構名古屋医療センター(愛知)
National Hospital Organization Kyushu Cancer Center (Fukuoka), National Hospital Organization Nagoya Medical Center (Aichi),

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 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
2013 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 01 Day
Last modified on
2013 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012145

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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