Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma

Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma - S-1 for thymic carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010736

Enrollment

Registered

2013-05-16

Start date

2013-05-01

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

S-1 treatment: S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day) with basing on the BSA for 2 weeks-on, which is followed by 1 week-off. Cycl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patients who were definitively diagnosed with having thymic carcinoma 2. Unsuitable for curative-intent treatment and previously treated with at least 1 prior cisplatin-based chemotherapy 3. Age of 18 years or older 4. ECOG performance status 0-2 5. presence of measurable lesion with RECIST 1.1 criteria 6. With the status of previous treatment (surgery, radiotherapy, or chemotherapy) at the time of beginning of S-1 chemotherapy 7. Adequate organ function 8. Life expectancy of at least 12 weeks 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. With severe drug allergies for tegafur 2. With severe myleosuppression, renal disturbance, or liver disturbance 3. Current use of flucytosine 4. With severe uncontrolled systemic complication 5. Serious uncontrolled infections 6. With concrrent other malignant tumro 7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 8. With continuous diarrhea 9. With bowel paralysis or obstruction 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11.Symptomatic or uncontrolled brain metastasis 12. The patients treated with unapproved drugs within 30 days 13. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 14. Unable to intake orally

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression-free survival, overall survival, toxicity, number of cycles	—

Countries

Japan

Contacts

Public ContactYusuke Okuma

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine

y-okuma@cick.jp03-3823-2101

Outcome results

None listed

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