Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000012098
• Date of registration: 22/10/2013
• Prospective Registration: Yes
• Primary sponsor: Tokushukai Group Oncology Project
• Public title: Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer
• Scientific title: Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer - Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Non-small Cell Lung Cancer
• Date of first enrolment: 2013/11/11
• Target sample size: 45
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014120
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: TAKEDA Takayuki
• Affiliation: Uji-Tokushukai Medical Center Department of Respiratory Medicine

• Name: TAKEDA Takayuki
• Affiliation: Uji-Tokushukai Medical Center Department of Respiratory Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Past history of severe drug hypersensitivity 2) Severe bone marrow suppression, renal dysfunction, or liver dysfunction 3) Treatment history of S-1, except for the cases in which S-1 had been administered as adjuvant chemotherapy and recurrence was observed more than 1 year after thoracic surgery 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer 5) Severe complication such as ileus, interstitial pneumonia, uncontrolled diabetes, heart failure, renal dysfunction, liver dysfunction, active digestive ulcer, and acute myocardial infarction or angina pectoris within six months 6) Diarrhea graded 2 or more 7) Active infectious disease in need of systemic administration of antibiotics 8) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage 9) Uncontrolled symptomatic brain metastasis 10) Systemic administration of steroid 11) Patients with psychiatric disease or symptoms, who seem to have difficulty in participating in the study 12) Any patients judged by the investigator to be unfit to participate in the study

Age minimum: 75years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Induction chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) plus carboplatin at the dose of area under the curve 5 (Day 1) every 3 weeks, up to 4 cycles. Continuation maintenance chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) until PD is observed.

Primary Outcome(s)

Progression-free survival

Secondary Outcome(s)

Response rate, safety and adverse event, 1-year survival rate, overall survival

Source(s) of Monetary Support

Uji-Tokushukai Medical Center

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/12/2016