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A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer

A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer - A phase II study of induction chemoradiotherapy plus surgery in patients with stage III non-small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005801
Enrollment
35
Registered
2011-06-20
Start date
2011-06-01
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

Non small cell lung cancer

Interventions

Preoperative Chemotherapy (1) Docetaxel (DOC) 250ml infusion of glucose injection, saline solution, mixed with an electrolyte maintenance solution, intravenous infusion over 60 min. (2) Carboplatin

Sponsors

Toho University Omori Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: lung cancer 2) Patients showed pathological mediastinal lymph node metastases , FDG-PET and chest CT scans showed significant enlargement of mediastinal lymph nodes on patients with N2. Or, in the thoracic organ tumors (heart, major blood vessel, trachea, and vertebrate ) patients with T4 invasion admit. 3) No history of radiotherapy and chemotherapy in initial treatment for lung cancer 4) Over 20 years of age, less than 75 years old 5) ECOG Performance status :0-1 6) Patients with adequate organ function WBC 4000/mm3 or more, 12000/mm3 less Hb 10.0g/dl Plt 100000/mm3 more GOT, GPT 2 times the upper limit of normal for the facility T. Bil 1.5mg/dl or less sCr 1.5mg/dl or less PaO2 70Torr more Than expected after FEV1.0 0.8L 7) Measurable disease (at least 1 target lesion 2cm or more) Patients 8) Written Informed concent was obtained in those patients

Exclusion criteria

Exclusion criteria: ) Blood transfusion within 14 days of therapy before enrollment, and preparations are treated with hematopoietic factor, those patients treated with antithrombotic agents for thrombosis. 2) Severe renal dysfunction, or urine protein 2+ or more cases. 3) Patient with severe drug allergy (anaphylaxis) 4) Patients with active double cancer 5) Patients with infectious diseases as a clinical problem, and suspected. 6) Poorly controlled hypertension, or patients with diabetes. 7) Significant ECG abnormalities, patients with heart disease as a clinical problem. 8) Patients with a history mager of Thrombosis or thrombosis severe lung disease within one year of the merger or previous thrombosis, severe lung disease (interstitial pneumonitis, pulmonary fibrosis, severe emphysema, etc.) within one year. 9) Patients with non-healing traumatic fracture 10) Patients with a history of mental disability, central nervus system disorder, cerebrovascular disease 11) In addition, patients who are considered not to participate in the study by doctor.

Design outcomes

Primary

MeasureTime frame
Response rate (ORR) Overall survival (OS)

Secondary

MeasureTime frame
Histological effects Complete resection Progression free survival (PFS) Safety 2-year survival rate

Countries

Japan

Contacts

Public ContactKazutoshi Isobe

Toho University Omori Medical Center Division of Respiratory Medicine

kazutoshiisobe@aol.com03-3762-4151

Outcome results

None listed

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