UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010428 |
|---|---|
| Receipt number | R000012197 |
| Scientific Title | A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation for Stage III non-small cell lung cancer |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2019/08/20 16:30:24 |
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Basic information
Public title
A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation
for Stage III non-small cell lung cancer
Acronym
A phase II study of chemoradiotherapy with IF-RT and AHF for Stage III NSCLC
Scientific Title
A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation
for Stage III non-small cell lung cancer
Scientific Title:Acronym
A phase II study of chemoradiotherapy with IF-RT and AHF for Stage III NSCLC
Region
| Japan |
Condition
Condition
Stage III non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of chemoradiotheray with use of involved-field conformal radiotherapy and accelerated hyperfractionation
for Stage III non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year survival ratio
Key secondary outcomes
Annual year survival ratio, Median survival time, Local control rate, The ratio of the patients who completed the course, Adverse events
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 | Device,equipment |
Interventions/Control_1
Concurrent chemotherapy(carboplatin [CBDCA] -AUC 2mg/ml min day 1, paclitaxel [PTX] -40mg/m^2 day 1)is weekly given for 4 cycles.
Twice daily radiotherapy (1.5Gy/fr, total dose; 66Gy) using 3D-CRT starts on day 1, followed by 2 cycles of consolidation chemotherapy ( CBDCA-AUC 5mg/ml min day 1 plus PTX-200mg/m^2 day 1).
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) Histologically or cytologically confirmed NSCLC.
(2) Expected more than 90 days survival.
(3) Stage IIIA, IIIB based on General Rule for Clinical and Pathological Record of Lung Cancer (The 7th Edition) without the treatment history of chemotherapy, radiotherapy and surgery (except explorative thoracotomy).
(4)Unexpected complete tumor resection.
(5)Expected completion of planed radiotherapy judged by a radiation oncologist, based on 3-dimentional radiotherapy planning
V20 of the lung <=35%
PRV of the spinal cord Dmax <=52Gy
Dmax of the esophagus <=68Gy
V50 of the esophagus<=50%
(6) ECOG performance status 0-1
(7) Patients are >=20 years and < 75 years of age at the time of signature of the informed consent.
(8) Adequate major organ function (including bone-marrow, heart, liver, renal function) as assessed by standard laboratory criteria as follows:
White blood cell>=4,000/mm3
Platelet>=100,000/mm3
Hemoglobin>=9.5g/dl
AST,ALT<=100IU/L
Total bilirubin<=1.5 mg/dL
Creatinin<=1.5mg/dL
PaO2 (room air) >=70Torr
(9) Written informed consent
Key exclusion criteria
(1)Chest CT shows active interstitial pneumonia or pulmonary fibrosis or severe pulmonary emphysema.
(2)The patient has SVC syndrome.
(3)The patient has one or more nodal metastases as listed below; supraclavicular node, anterior scalene node, contralateral hilar node. These nodes are assumed as positive if they are FDG/PET positive and have more than 5mm diameter.
Malignant pleural effusion, malignant pericardial effusion and malignant lymphangitis are also ineligible.
(4)The patient has a history of previous thoracic radiotherapy.
(5)The patient has active previous or concomitant malignancies.
(6)The patient has uncontrolled diabetes mellitus.
(7) The patients has active local or
systemic infection, which should
be treated.
(8)The patient has a severe complication (ex.gastrointestinal bleeding, heart disease, glaucoma, HIV infection).
(9) The patient has a history of
allergy against agents containing polyoxyethilene oil or severe drug allergy.
(10) The patient has psychiatric
disorders that may comprise the patient s ability to comply with the study.
(11) Positive serum HBs antigen or HCV antibody.
(12) The patient is pregnant, may be
pregnant, or is lacting.
The patient, if is of child-bearing
potential, does not practice contraception.
(13) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masako Hosono |
Organization
Osaka City University Hospital
Division name
Dept of Radiology
Zip code
Address
1-4-3, Asahimachi, Abenoku,
TEL
06-6645-3831
mhosono@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka
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
| 2013 | Year | 04 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 11 | Day |
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 | 05 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012197
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