UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005801 |
|---|---|
| Receipt number | R000006865 |
| Scientific Title | A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2014/12/19 23:18:21 |
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Basic information
Public title
A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer
Acronym
A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer
Scientific Title
A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer
Scientific Title:Acronym
A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective of this study to investigate efficacy and safety for stageIII Non small cell lung cancer with neoadjuvant chemoradiotherapy plus surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (ORR)
Overall survival (OS)
Key secondary outcomes
Histological effects
Complete resection
Progression free survival (PFS)
Safety
2-year survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative Chemotherapy
(1) Docetaxel (DOC)
250ml infusion of glucose injection, saline solution, mixed with an electrolyte maintenance solution, intravenous infusion over 60 min.
(2) Carboplatin (CBDCA)
250ml infusion of glucose injection, saline solution, mixed with an electrolyte maintenance solution, intravenous infusion over 60 min. The order of administration is 1st DOC 2nd CBDCA.
(3) Timing of administration
CBDCA AUC3 d1,d15
Postoperative radiation therapy
(1) exposure
2Gy/20 fractions (total 40Gy)
(2) The time of irradiation
Chemotherapy (first course) day2 from the start. For information about setting the radiation field depends on the hospital radiologists.
DOC 30mg/m2 d1,d15
Two courses carried out every four weeks.
Operative therapy
(1) eligible patients
Antitumor effect was observed in SD preoperative radiation or chemotherapy to surgery for patients in PR judges decision.
(2) Operative procedure
Curative lung resection and mediastinal lymph node dissection
(3) Timing of surgery
Chemotherapy after resection was performed 2-4 weeks later.
neligible patients
PD patients had preoperative chemotherapy and surgery are not determined, post treatment is assumed to be free
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
lung cancer
2) Patients showed pathological mediastinal lymph node metastases
, FDG-PET and chest CT scans showed significant enlargement of mediastinal lymph nodes on patients with N2. Or, in the thoracic organ tumors (heart, major blood vessel, trachea, and vertebrate ) patients with T4 invasion admit.
3) No history of radiotherapy and chemotherapy in initial treatment for lung cancer
4) Over 20 years of age, less than 75 years old
5) ECOG Performance status :0-1
6) Patients with adequate organ function
WBC 4000/mm3 or more, 12000/mm3 less
Hb 10.0g/dl
Plt 100000/mm3 more
GOT, GPT 2 times the upper limit of normal for the facility
T. Bil 1.5mg/dl or less
sCr 1.5mg/dl or less
PaO2 70Torr more
Than expected after FEV1.0 0.8L
7) Measurable disease (at least 1 target lesion 2cm or more) Patients
8) Written Informed concent was obtained in those patients
Key exclusion criteria
) Blood transfusion within 14 days of therapy before enrollment, and preparations are treated with hematopoietic factor, those patients treated with antithrombotic agents for thrombosis.
2) Severe renal dysfunction, or urine protein 2+ or more cases.
3) Patient with severe drug allergy (anaphylaxis)
4) Patients with active double cancer
5) Patients with infectious diseases as a clinical problem, and suspected.
6) Poorly controlled hypertension, or patients with diabetes.
7) Significant ECG abnormalities, patients with heart disease as a clinical problem.
8) Patients with a history mager of Thrombosis or thrombosis severe lung disease within one year of the merger or previous thrombosis, severe lung disease (interstitial pneumonitis, pulmonary fibrosis, severe emphysema, etc.) within one year.
9) Patients with non-healing traumatic fracture
10) Patients with a history of mental disability, central nervus system disorder, cerebrovascular disease
11) In addition, patients who are considered not to participate in the study by doctor.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakae Homma |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku Tokyo 143-8541 Japan
TEL
03-3762-4151
kazutoshiisobe@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
kazutoshiisobe@aol.com
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
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
東邦大学医療センター大森病院(東京都）/ Toho Univ. Omori Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 06 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006865
