UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000085
Receipt number 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 19:41:06

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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 or person

Institute

Okayama Lung Cancer Study Group (OLCSG)

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


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

Value
https://center6.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