Unique ID issued by UMIN | C000000085 |
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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 |
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)
OLCSG0007
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)
OLCSG0007
Japan |
inoperable locally advanced non-small-cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
Phase III
overall survival
response rate
progression-free survival
pattern of progression/relapse
adverse events
treatment compliance
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
combination chemotherapy of cisplatin and docetaxel with concurrent thoracic radiation therapy
combination chemotherapy of mitomycin, vindesine and cisplatin with concurrent thoracic radiation therapy
Not applicable |
75 | years-old | >= |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | Mitsune Tanimoto, M.D., Ph.D., Professor & Chairman |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Department of Hematology, Oncology, and Respiratory Medicine
2-5-1 Shikata-cho, Okayama 700-8558
086-235-7224
1st name | |
Middle name | |
Last name | Katsuyuki Kiura, M.D., Ph.D. |
Okayama Lung Cancer Study Group Coordinating Office
Respiratory Medicine (Thoracic Oncology)
2-5-1 Shikata-cho, Okayama 700-8558
086-235-7225
kkiura@md.okayama-u.ac.jp
Okayama Lung Cancer Study Group (OLCSG)
NONE
Self funding
NO
2005 | Year | 09 | Month | 12 | Day |
Published
http://jco.ascopubs.org/content/28/20/3299.long
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.
Completed
2000 | Year | 07 | Month | 07 | Day |
2000 | Year | 07 | Month | 01 | Day |
2006 | Year | 04 | Month | 01 | Day |
2006 | Year | 04 | Month | 01 | Day |
2006 | Year | 04 | Month | 01 | Day |
2007 | Year | 06 | Month | 01 | Day |
J Clin Oncol. 2010 Jul 10;28(20):3299-306. Epub 2010 Jun 7
2005 | Year | 08 | Month | 29 | Day |
2016 | Year | 09 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000129
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