A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced squamous cell lung cancer

A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced squamous cell lung cancer - Nedaplatin and thoracic radiation Phase 1

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021226

Enrollment

Registered

2016-02-29

Start date

2016-03-01

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

elderly patients with locally advanced squamous cell lung cancer

Interventions

Combination of Nedaplatin and concurrent thoracic radiotherapy 2Gy/day for 30 times. The dose escalation of Nedaplatin is conducted from 20 to 30 mg/m2 according to standard 3+3 design.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Cytologically or histologically comfirmed squamous cell carcinoma of the lung 2 Previously untreated and unresectable Stage 3A or 3B 3 patients aged 75 and more years old who are amenable for standard chemo- radiotherapy 4 Eastern Cooperative Oncology Group Performance Status 0 to 1 5 An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 6 Have adequate organ function within two week before study entry a)leukocyte 3000/mm3 or higher b)absolute neutrophil count 1500/mm3 or higher c) hemoglobin consentration 9.0g/dl or higher d) serum AST and ALT 2.5 times of the institutional upper limits of normal or lower e) serum bilirubin 1.5mg/dl or lower f) serum creatinine 1.2mg/dl or lower g) creatinine clearance 60ml/min or higher 7 Have signed an informed consent document

Exclusion criteria

Exclusion criteria: 1) SVC syndrome 2) Pulmonary fibrosis and interstitial pneumonitis 3) With active double cancer 4) With active infection, poorly controlled diabetes, and serious cardiac diseases 5) Patients with steroid treatment 6) Clinically significant drug allergy 7) Uncontrolled psychiatric disease. 8) Positive serum HBs antigen or HCV antibody 9) Others

Design outcomes

Primary

Measure	Time frame
To determine the recommended dose and assess the safety of chemoradiotherapy with nedaplatin and thoracic radiation	—

Secondary

Measure	Time frame
response rate, progression free survival, overall survival, 2 year survival rate, , completion rate of chemoradiotherapy, the rate of occurrence of grade 3 and more radiation pneumonitis	—

Countries

Japan

Contacts

Public ContactYosuke Tamura

Osaka medical college hospital First Department of Internal Medicine

in1285@osaka-med.ac.jp072-683-1221

Outcome results

None listed

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