A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.

UMIN ID: UMIN000002162

Registered date:03/07/2009

Basic Information

• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Radiation: using 6-10MV X-ray, daily 2Gy, 5 days/week until 64Gy. TS-1: TS-1 (each level) is administered orally on days 1-14 every 21 days.

Outcome(s)

• Primary Outcome: To determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.
• Secondary Outcome: Adverse events for treatment (56days) or after 56days, Response rate (RR), Overall survival (OS), Disease control rate, Disease free survival (DFS)

Key inclusion & exclusion criteria

• Age minimum: 75years-old
• Age maximum: 89years-old
• Gender: Male and Female
• Exclude criteria: 1 patient with marked fever and suspected infection 2 patient has dreaded complication 3 concomittant active malignancy 4 needing teratment pleulal effusion and hydroperitoneum syndrome 5 patient of the pericardium water retension syndrome 6 patient has chicken pox 7 Serious neuropathy 8 Anarmnesis of drug allergy 9 Severe bone marrow suppression 10 serious renal function disturbance 11 serious liver function disturbance 12 taking other fluoropyrimidime 13 Under treatment with flucytosine 14 Not suitable for participating in the study for any othe reason

Related Information

• Primary Sponsor: Hiroshima Radiation Oncology Study Group
• Source(s) of Monetary Support: None