UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000174 |
|---|---|
| Receipt number | R000000246 |
| Scientific Title | A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer. |
| Date of disclosure of the study information | 2005/09/14 |
| Last modified on | 2016/04/26 17:05:32 |
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Basic information
Public title
A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Acronym
Phase III trial of chemotherapy versus chemoradiotherapy before surgery in stage IIIA-N2 NSCLC
Scientific Title
A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.
Scientific Title:Acronym
Phase III trial of chemotherapy versus chemoradiotherapy before surgery in stage IIIA-N2 NSCLC
Region
| Japan |
Condition
Condition
Pathologically confirmed stage IIIA-N2 non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the multicenter randomized phase III study is to evaluate the safety and effectiveness of preoperative chemotherapy or concurrent chemoradiotherapy followed by surgery in patients with pathologically-proved stage IIIA-N2 non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Five-year survival
Key secondary outcomes
toxicity of a preoperative treatment and a response rate, resection rate, complete resection rate, unresectable rate, downstaging rate, postoperative mortality and morbidity, hospital mortality, disease-free survival rate, median survival time, pattern of recurrence (first site of relapse)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bimodality therapy group: two courses of systemic chemotherapy followed by surgeryTrimodality therapy group: two courses of systemic chemotherapy with concurrent thoracic radiotherapy followed by surgeryChemotherapy regimen consists of carboplatin and docetaxel on day 1. Two courses of chemotherapy with 3 weeks interval is plannedPatients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.
Interventions/Control_2
Radiotherapy begins on day 1, concurrently with chemotherapy.(The total dose of radiation is 40 Gy, 2 Gy/fraction/day)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathological diagnosis of non-small cell lung cancer is necessary. Ipsilateral pathologically-proved mediastinal lymph node with shortest diameter of larger than 1 cm is required.2) Pretreatment lesions are respectable without extranodal invasion. 3) No prior treatment for lung cancer4) Measurable disease5) Age 20 to 70 years6) Performance status (ECOG criteria) 0-17) Adequate organ functions
WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul, T.Bil less than 1.5mg/dl, serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 40mg/dl, PaO2 more than 70torr, Forced expiratory volume in 1 secnd more than 1.5L
8) No prior chemotherapy or radiotherapy for the treatment of other malignancies is essential.9) Written informed consent to participate in the trial is necessary
Key exclusion criteria
1)Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of completely resected early gastric cancer,uterine cervical cancer, completely resected skin malignancies (except malignant melanoma)are acceptable.
2)Uncontrollable angina or myocardial infarction within the past 3 months. Severe heart disease, arrhythmia requiring treatment.
3)Uncontrollable hypertension and Diabetes Mellitus.
4)Patients with severe COPD (FEV1.0percent less than 65)or pulmonary fibrosis recognized with computed tomography scanning.
5)Weight loss more than 10 percent within the past 6 months
6)Women during pregnancy or lactating.
7)ther unsuitable patient judged by a physician.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Kobe City General Hospital
Division name
Division of pulmonary medicine
Zip code
Address
4-6, Minatojima Nakamachi Chuo-ku,Kobe 650-0046, Japan
TEL
078-302-4321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2005 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=22674529
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
Completed
Date of protocol fixation
| 2000 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000246
