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)

UMIN ID: C000000085

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: inoperable locally advanced non-small-cell lung cancer
• Date of first enrollment: 2000/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

combination chemotherapy of cisplatin and docetaxel with concurrent thoracic radiation therapy
combination chemotherapy of mitomycin, vindesine and cisplatin with concurrent thoracic radiation therapy

Outcome(s)

• Primary Outcome: overall survival

Secondary Outcome

response rate
progression-free survival
pattern of progression/relapse
adverse events
treatment compliance

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Okayama Lung Cancer Study Group (OLCSG)
• Source(s) of Monetary Support: NONE