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A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)

A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302) - S-1 monotherapy for relapsed thymoma and thymic carcinoma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009845
Enrollment
30
Registered
2013-02-01
Start date
2013-02-01
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

Thymoma/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), depending on the BSA from days 1 to 14, which is followed by 7 days rest.

Sponsors

Okayama Lung Cancer Study Group(OLCSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically proven thymoma or thymic carcinoma 2. Unsuitable for curative radiotherapy or Unresectable 3. At least 1 prior chemotherapy 4. Progressive disease after the most recent chemotherapy regimen. 5. ECOG performance status 0-2 6. Age of 20 years or older 7. Presence of measurable lesions, as defined per RECIST 1.1 8. Adequate organ function 9. Life expectancy of at least 2 months 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Serious uncontrolled infections or body temperature higher than 38 degree centigrade 2. Continuous administration of an oral steroid or an immunosuppressive agent 3. With severe concurrent disease 4. Symptomatic brain metastasis 5. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 6. With severe drug allergies 7. Contraindication with S-1 8. Previous treatment with fluoropyrimidines such as S-1, UFT 9. Current use of flucytosine 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 12. Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

MeasureTime frame
Progression free survival

Countries

Japan

Contacts

Public ContactYuka Kato

Okayama University Hospital Department of Allergy and Respiratory Medicine

086-235-7227

Outcome results

None listed

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