UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010386 |
|---|---|
| Receipt number | 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 16:50:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012145
