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A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma - LOGIK1605/JART-1501

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071180046
Enrollment
30
Registered
2019-03-14
Start date
2017-01-31
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

Thymic carcinoma

Interventions

1) S-1 is orally administered twice a day at day 1-14 and day 29- 42.Dose of S-1: 80mg/m2/day, 40mg/m2/dose x 2 times 2) Cisplatin 60 mg/m2/day at day 1 and day29. 3) Daily radiation at 2.0 Gy/ti

Sponsors

Fukuda Minoru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with thymic carcinoma confirmed histologically. 2. Patients without treatment history of chemotherapy,radiation and surgical resection for thymic carcinoma. 3. Patients with unresectable locally advanced cancer and with Masaoka stage classification, stage III. Eligible for only metastasis to supraclavicular fossa or mediastinal lymph node with Masaoka stage classification, stage IVb. 4. Patients who is judged that radical irradiation is possible by a treatment plan of radiotherapist. 5. Patients without active double cancer. 6. Patient is at least 20 years of age (at enrollment date). 7. Performance status (ECOG): 0-1 8. The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard. 1) WBC >= 3000/mm3 or neutrophil count >=1,500/mm3 2) Hemoglobin >= 9.0g/dL 3) Platelet count>= 100,000/mm3 4) AST, ALT = 60 mL/min (Cockcroft-Gault method, 24 hrs method) 7) PaO2 >= 60 Torr or SpO2 >= 90% 9. Patients providing the written informed consent. 10. Patients with life expectancy of at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients who requires urgent radiation therapy with a symptom of superior vena cava syndrome 2. Patients with serious complications : such as uncontrollable angina pectoris, myocardial infarction within 3 months and heart failure, uncontrollable diabetes mellitus,hypertension and serious infection. 3. Patients with interstitial pneumonia confirmed by chest X-ray. 4. Patients having complications judged to affect the enforcement of treatment. 5. Patients with anamnesis of severe hypersensitivity. 6. Patients with pregnant or possibly pregnant. Patients with nursing. 7. Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 8. Any other patients who are regarded as unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
Overall survival (OS) Progression free survival (PFS) Adverse event (AE)

Contacts

Public ContactMinoru Fukuda

Nagasaki University Hospital

mifukuda@nagasaki-u.ac.jp+81-95-819-7779

Outcome results

None listed

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