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

JRCT ID: jRCTs071180046

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Thymic carcinoma
• Date of first enrollment: 31/01/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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/time from day 1 for 5times /weeks,
total 30 times. Total radiation 60Gy.
If the apparent effect of tumor reduction is observed by
protocol treatment and a surgical resection is ethically
required, surgical resection is applicable.

Outcome(s)

• Primary Outcome: response rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Fukuda Minoru