A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer

A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer - A phase II study of preoperative concurrent chemoradiotherapy for non-small-cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000599

Enrollment

Registered

2007-02-08

Start date

2007-01-01

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

resectable locally advanced non small cell lung cancer

Interventions

Two courses of chemotherapy with cisplatin (40 mg m-2) and docetaxel (40 mg m-2) with 3 weeks interval is planned. A total radiation dose of 40 Gy is planned with conventional fractionation (2 Gy day-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Pathological diagnosis of non-small cell lung cancer is necessary. Lesions should be surgically respectable. b) Age = or < 70 years c) No prior treatment for lung cancer d) stage IIIA or IIIB with pathologically-proved mediastinal lymph node. Patients with mediastinal LN of shortest diameter of larger than 1 cm, T2-4, or CEA > 10ng/ml are required to undergo mediastinoscopy. Mediastinal lymph node biopsy should be done for bilateral #1-4, and #7. e) Performance status (ECOG criteria) 0-1 f) Resection index should be more than 30. g) No other primary cancers within past 5 years and no active cancers h) Adequate bone marrow function WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul. i) Adequate liver function (T.Bil less than 1.5mg/dl, AST/ALT less than 2.5 times of normal range.) j) Adequate renal level. (serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 60mg/dl) k) Adequate pulmonary function (PaO2 more than 70torr) l) No other severe complications. Agreement for the protocol by physicians, surgeons and radiologists is essential. m) Written informed consent to participate in the trial is necessary

Exclusion criteria

Exclusion criteria: a) Malignant pleuritis or malignant pericarditis. b) Pleural dissemination. c) Positive suplra calavicle nodes. d) Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of chemotherapy or thoracic irradiation are not acceptable. e) Patients with severe complications. 1) Pulmonary fibrosis recognized with computed tomography scanning. 2)Severe heart disease.(Uncontrollable angina or myocardial infarction within the past 3 months) 3) Uncontrollable Diabetes Mellitus. 4) Severe infectious disease 5) Other unsuitable patient judged by a physician. f) Women during pregnancy or lactating.

Design outcomes

Primary

Measure	Time frame
3-year survival	—

Secondary

Measure	Time frame
the rate of complete resection pathological response of preoperative therapy(down staging, pathological CR) Progression free survival toxicities	—

Countries

Japan

Contacts

Public ContactHiromasa Yamamoto

Okayama University Hospital Department of Thoracic Surgery

h.yamamoto@md.okayama-u.ac.jp086-235-7265

Outcome results

None listed

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