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

Phase 2

• Conditions: Thymic carcinoma

• Registration Number: JPRN-jRCTs071180046
• Lead Sponsor: Fukuda Minoru

Brief Summary

A phase 2 study of S-1/Cisplatin plus concurrent radiotherapy was conducted for locally advanced thymic carcinoma. Three cases were enrolled. One evaluable case was stable disease and had a response rate of 0%. The median progression-free survival, median overall survival, 1-, 2-, 3 years survival rates of 3 patients were 17.6 months, not reach, 100%, 67%, 67%, respectively. Two patients were not evaluable due to delayed start of the 2nd cycle of study treatment, but subsequently achieved complete remission

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Study Completion: 2020-10-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

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 < 100 IU/L
5) Total bilirubin <= 1.5mg/dL
6) Creatinine clearance >= 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)<br>Progression free survival (PFS) <br>Adverse event (AE)