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.

Phase 1

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

• Registration Number: JPRN-jRCT1041230096
• Lead Sponsor: Akita Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-21
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 12

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< years; (5) ability to keep appropriate body position for radio therapy, (6) dose constraints for organs at risk achievable; (7) no previous radiation therapy around the lesion, (8) no previous chemotherapy; (9) lesion evaluable by the Response Evaluation Criteria in Solid Tumors (RECIST); (10) adequate organ function (in the previous 14 days), SpO2>=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 <1.5 mg/dl, aspartate aminotransferase and alanine aminotransferase <2 x NL IU/l), and creatinine <1.5 mg/dl, creatinine clearance >=60 ml/min). (11) expected sprognosis of 2months or more; and (12) written informed consent.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the maximally tolerable dose with acceptable toxicity profile.

Secondary Outcome Measures

Name	Time	Method
Toxicity profile, Response,