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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000085

Enrollment

200

Registered

2005-09-12

Start date

2000-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inoperable locally advanced non-small-cell lung cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
response rate progression-free survival pattern of progression/relapse adverse events treatment compliance	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026