Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000009345
• Lead Sponsor: Okayama Lung Cancer Study Group

Brief Summary

Carboplatin plus S-1 had favorable efficacy and tolerable toxicity for the elderly with NSCLC. This study met the predesigned primary endpoint, and the regimen seems to be a potent treatment option. Low TP expression in tumors might serve as a predictive maker of a better DCR. We need to conduct further studies to evaluate whether this combination is superior to the standard first-line treatment for the elderly.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with brain metastases with the clinical symptoms 2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity 3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion) 4) Patients with a history of severe drug allergy 5) Pregnancy, breast feeding or wish of future bearing 6) Patients with severe complication Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months) Uncontrollable diabetes mellitus Patients with severe infection Patients has pleural effusion, pericardial effusion and ascites to be treated 7) Patients who need to be treated by radiotherapy in an urgent 8) concomitant therapy with other pyrimidine fluoride antineoplastic agents 9) concomitant therapy with warfarin 10) concomitant therapy with dabigatran etexilate 11) Principal investigator cases that are deemed inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified