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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000085
Receipt No. R000000129
Scientific Title Randomized, comparative clinical study of cisplatin and docetaxel combination chemotherapy and mitomycin, vindesine and cisplatin (MVP) combination chemotherapy with concurrent thoracic radiation therapy for locally advanced unresectable non-small-cell lung cancer (OLCSG0007)
Date of disclosure of the study information 2005/09/12
Last modified on 2016/09/15

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Basic information
Public title Randomized, comparative clinical study of cisplatin and docetaxel combination chemotherapy and mitomycin, vindesine and cisplatin (MVP) combination chemotherapy with concurrent thoracic radiation therapy for locally advanced unresectable non-small-cell lung cancer (OLCSG0007)
Acronym OLCSG0007
Scientific Title Randomized, comparative clinical study of cisplatin and docetaxel combination chemotherapy and mitomycin, vindesine and cisplatin (MVP) combination chemotherapy with concurrent thoracic radiation therapy for locally advanced unresectable non-small-cell lung cancer (OLCSG0007)
Scientific Title:Acronym OLCSG0007
Region
Japan

Condition
Condition inoperable locally advanced non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To improve the treatment results for patients with locally advanced unresectable NSCLC, it is necessary to investigate (1) the timing of concurrent administration of chemotherapy with radiation therapy, (2) the optimal regimen for the concurrent chemotherapy, (3) the method for fractionation of the thoracic radiation, etc. In regard to the timing of concurrent administration, the West Japan Thoracic Oncology Group (WJTOG) carried out a phase III comparative clinical study of thoracic radiation and a mitomycin, vindesine and cisplatin (MVP) regimen, with the radiation administered either concurrently or sequentially with the chemotherapy. They reported that the duration of survival was superior in the case of the concurrently administered radiation therapy.
The present study was planned with the objective of investigating the optimal chemotherapy regimen for use in concurrent administration of thoracic radiation and chemotherapy in the treatment of patients with locally advanced unresectable non small-cell lung cancer. Accordingly, this study is designed as a randomized, comparative study (a phase III study) of a cisplatin and docetaxel combination therapy and a mitomycin, vindesine and cisplatin (MVP) combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes response rate
progression-free survival
pattern of progression/relapse
adverse events
treatment compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination chemotherapy of cisplatin and docetaxel with concurrent thoracic radiation therapy
Interventions/Control_2 combination chemotherapy of mitomycin, vindesine and cisplatin with concurrent thoracic radiation therapy
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Histologically or cytologically confirmed non-small-cell lung cancer
No prior therapy
Age: 75 years or less
Disease stage of unresectable IIIA (bulky N2) or IIIB
ECOG performance status of 0 or 1
Measurable lesion(s)
Adequate bone marrow function
WBC 4,000/cmm or more; PLT 100,000/cmm or more
Adequate liver function
T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution
Adequate kidney function
Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more
Adequate pulmonary function
Pa02 60 Torr or more
However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement.
Acquisition of written informed consent
Key exclusion criteria Presence of malignant pleural effusion or malignant pericardial fluid
Presence of pleural dissemination
Presence of active double cancers
Even in the case of asynchronous double cancers, the patient will be excluded if there is a past history of chemotherapy or thoracic radiotherapy.

Presence of serious complications
1)Interstitial pneumonia
2)Serious heart disease (e.g., difficult to control angina pectoris, myocardial infarction within the past 3 months, etc.)
3)Difficult to control diabetes mellitus
4)Serious infection
5)Presence of any other complications which can be thought to represent a serious impediment to performance of the therapy

Pregnancy, breast feeding or the intention to become pregnant
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsune Tanimoto, M.D., Ph.D., Professor & Chairman
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Division name Department of Hematology, Oncology, and Respiratory Medicine
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558
TEL 086-235-7224
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Kiura, M.D., Ph.D.
Organization Okayama Lung Cancer Study Group Coordinating Office
Division name Respiratory Medicine (Thoracic Oncology)
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558
TEL 086-235-7225
Homepage URL
Email kkiura@md.okayama-u.ac.jp

Sponsor
Institute Okayama Lung Cancer Study Group (OLCSG)
Institute
Department

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
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
2005 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jco.ascopubs.org/content/28/20/3299.long
Number of participants that the trial has enrolled
Results
Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and
23.7 months, respectively), which was not statistically significant (P > .05).
Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm
(39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was
likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). 
CONCLUSION: DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.
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 07 Month 07 Day
Date of IRB
Anticipated trial start date
2000 Year 07 Month 01 Day
Last follow-up date
2006 Year 04 Month 01 Day
Date of closure to data entry
2006 Year 04 Month 01 Day
Date trial data considered complete
2006 Year 04 Month 01 Day
Date analysis concluded
2007 Year 06 Month 01 Day

Other
Other related information J Clin Oncol. 2010 Jul 10;28(20):3299-306. Epub 2010 Jun 7

Management information
Registered date
2005 Year 08 Month 29 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000129

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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