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

A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer. - A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.(HTCARP-0001)

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002162

Enrollment

Registered

2009-07-03

Start date

2009-04-01

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

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed Non-small cell lung cancer 2) Measurable disease 3) Stage II-IIIB 4) Performance Status (ECOG) 0-2 5) more than 75 years old 6) never treatment for Non-small cell lung cancer 7) Adequate organ functions 8) Oral intake is possible 9) Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
To determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.	—

Secondary

Measure	Time frame
Adverse events for treatment (56days) or after 56days, Response rate (RR), Overall survival (OS), Disease control rate, Disease free survival (DFS)	—

Countries

Japan

Outcome results

None listed

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