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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011306
Receipt No. R000013243
Scientific Title Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)
Date of disclosure of the study information 2013/07/29
Last modified on 2013/11/05

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Basic information
Public title Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)
Acronym Adjuvant trial of CBDCA+TS1 followed by TS1 in completely resected stage II/IIA lung cancer. (JNETS1302)
Scientific Title Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)
Scientific Title:Acronym Adjuvant trial of CBDCA+TS1 followed by TS1 in completely resected stage II/IIA lung cancer. (JNETS1302)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of adjuvant CBDCA+TS1 followed by maintenance TS1 in patients with completely resected stage II-IIIA non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The ratio of the patients who completed the treatment
Key secondary outcomes

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 Carboplatin+TS1 followed by TS1 maintenance
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. ECOG performance status are 0 or 1.
2. Pathologically confirmed non-small cell lung cancer (NSCLC), except for low grade carcinoma such as carcinoid, mucoepidermoid carcinoma or adenoid cystic carcinoma.
3. Completely resected NSCLC by lobectomy or more
4. Lymph nodes dissection must be performed at the level of ND2a-1
5. Pathologically confirmed R0 resection.
6. Pathological stage II or IIIA
7. Within 2 months after surgical treatment
8. With adequate major organ functions within 14 days before trial entry, as defined below:
1) White blood cell count >= 3,000/mm3
2) Neutrophil count >= 1,500/mm3
3) Hemoglobin >= 8.0 g/dL
4) Platelet count >= 100,000/mm3
5) AST <= 100IU/L
6) ALT <= 100IU/L
7) Total Bilirubin<= 1.5 mg/dL
8) Serum Creatinine <= 1.5 mg/dL
9) SpO2 >= 95% at room air
10. Written informed consent must be taken by patients
Key exclusion criteria 1. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
2. With history of radiotherapy and/or chemotherapy for other disease including other cancer
3. With synchronous or metachronous (within 5 year before entry) multiple lung cancer
4. With synchronous or metachronous (within 5 year before entry) double cancer, except for curable cancer by local therapy such as in situ carcinoma
5. Severe surgical complication
6. Severe drug allergy
7. Severe complication; such as uncontrollable diabetes mellitus or hypertension
8. Positive for HBs antigen, HBs antibody, HBC antibody, HCV antibody or HIV antibody
9.Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
10. Men who have willing to become partner's pregnant
11.Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Fukushima Medical University
Division name Department of Chest surgery
Zip code
Address 1 Hikarigaoka Fukushima, Fukushima JAPAN
TEL 024-547-1253
Email hiro@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Endoh
Organization Tohoku University, school of medicine
Division name Department of Thoracic surgery
Zip code
Address 4-1, Seiryo-machi, Aoba-ku, Sendai Miyagi JAPAN
TEL 022-717-8526
Homepage URL
Email endo@idac.tohoku.ac.jp

Sponsor
Institute Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Institute
Department

Funding Source
Organization Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 29 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 07 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 04 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 07 Month 29 Day
Last modified on
2013 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013243

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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