A Phase I Dose Fnding Study of Weekly Cisplatin Plus S-1 with Concurrent Proton-beam (or Photon) Therapy for Elderly Patients with Inoperable Stage III Non-Small Cell Lung Cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041230096

Enrollment

Registered

2023-10-21

Start date

2023-10-23

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

Inoperable stage III Non-small Cell Lung Cancer elderly patients, inoperable stage III NSCLC, weekly cisplatin plus S1, concurrent chemo-radiotherapy

Interventions

All patients are admitted to hospital during the first course of chemotherapy. Chemotherapy consists of cisplatin at each dose levels (20, 25, 30 mg/m2) on days 1, 8 and S1 (40 mg/m2/dose) in the form

in a patient with a body surface area (BSA) 1.25 m2, 40 mg twice daily

for those with BSA 1.25 m2, but 1.5 m2, 50 mg twice daily

and BSA 1.5 m2, 60 mg twice daily. An antiemetic agent is administered at the discretion of each patients physician. The administration of cisplatin is skipped on day 8 if the patients met the follo

D002289

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria were as follows: (1) histologically or cytologically confirmed non-small cell lung cancer (NSCLC), (2) unresectable stage III NSCLC (TNM seventh edition); (3) Eastern Cooperative Oncology Group-Performance Status 1; (4) age 75 and 75=70%, ejection fraction >= 60%, white blood cell count (WBC)>=4000/mm3; neutrophils >=2000/mm3; hemoglobin >=9.0 g/dL; platelets >=100 000/mm3; total bilirubin =60 ml/min). (11) expected sprognosis of 2months or more; and (12) written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows: (1) superior vena cava syndrome; (2) other cancers within 5 years; (3) active and uncontrolled infection; (4) other serious complications; (5) obvious interstitial pneumonia or idiopathic pulmonary fibrosis on chest x-ray; (6) coronary stent and aortic stent graft; (7) history of severe hypersensitivity; (8) severe psychological disorders; (9) significant decline in cognition; (10) malignant pleural effusion; and (11) judged inappropriate by physician

Design outcomes

Primary

Measure	Time frame
To determine the maximally tolerable dose with acceptable toxicity profile.	—

Secondary

Measure	Time frame
Toxicity profile, Response,	—

Contacts

Public ContactKenji Akita

Nagoya City University West Medical Center

k.akita.86@west-med.jp+81-52-991-8121

Outcome results

None listed

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