UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026606 |
|---|---|
| Receipt number | R000030549 |
| Scientific Title | Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401 |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2017/03/18 17:13:31 |
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Basic information
Public title
Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401
Acronym
Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer.
Scientific Title
Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401
Scientific Title:Acronym
Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer.
Region
| Japan |
Condition
Condition
Locally Advanced Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety of weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point of the phase I study was to determine a recommended dosage of paclitaxel during the concurrent chemoradiotherapy part.
The primary endpoint of the phase II study was the response rate. Secondary endpoints were progression free survival, overall survival, and safety.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The phase I study was conducted to ascertain a recommended paclitaxel dosage. In the early part, chemotherapy consisted of paclitaxel (designated dosage) on days 1, 8, 15, 29, 36, and 43, and carboplatin (AUC 5 mg/mL/min) on days 1 and 29.
RTx:60 Gy in 2-Gy fractions over 6 weeks
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
Unresectable Locally Advanced Non-Small-Cell Lung Cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 age more than 20 years, less 75 years leucocytes more than 4,000/mm3, neutrocytes more than 2,000/mm3, platelets more than 100,000/mm3, haemoglobin more than 9.0 g/dL, serum creatinine less than 1.5 mg/dl, AST and ALT less than twice upper limit of normal, partial pressure of arterial oxygen greater than 70 mmHg, and no abnormality found from echocardiographic examination.
Key exclusion criteria
pulmonary fibrosis requiring oxygen therapy, myocardial infarction that occurred during the prior six months, liver cirrhosis, active haemorrhage of the digestive tract, mental disorder requiring treatment, diabetes mellitus in poor control, paresis of the intestine ileus, active infection, case with a history of radiation in the fields of radiation, allergy to polyoxyethylene component preparation, peripheral neuropathy, and pregnancy. Cases that a physician judged to be inadequate were also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motonari Fukui |
Organization
Tazuke Kofukai Medical Institute Kitano Hospital
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi, Kita-ku,Osaka
TEL
06-6312-1221
mfukui@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motonari Fukui |
Organization
Tazuke Kofukai Medical Institute Kitano Hospital
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi, Kita-ku,Osaka
TEL
06-6312-1221
Homepage URL
mfukui@kitano-hp.or.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 21 | 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
Completed
Date of protocol fixation
| 2004 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | 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
| 2017 | Year | 03 | Month | 18 | Day |
Last modified on
| 2017 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030549
