Unique ID issued by UMIN | UMIN000009845 |
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Receipt number | R000011537 |
Scientific Title | A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302) |
Date of disclosure of the study information | 2013/02/01 |
Last modified on | 2013/08/23 13:57:26 |
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.
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.
Japan |
Thymoma/Thymic carcinoma
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of S-1 monotherapy for relapsed thymoma or thymic carcinoma. Secondary endpoints are progression free survival and overall survival. And also to analyse correlation between efficacy of S-1 treatment and expression of fluoropyrimidine metabolizing enzyme such as TS, DPD, OPRT.
Efficacy
Progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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. Courses of S-1 treatment will be repeated every 3weeks until discontinuation criteria are met.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Katsuyuki Kiura |
Okayama University Hospital
Department of Allergy and Respiratory Medicine
2-5-1, shikatacho, kitaku, okayama
1st name | |
Middle name | |
Last name | Yuka Kato |
Okayama University Hospital
Department of Allergy and Respiratory Medicine
086-235-7227
Okayama Lung Cancer Study Group(OLCSG)
Okayama University Hospital
Self funding
NO
2013 | Year | 02 | Month | 01 | Day |
Unpublished
Terminated
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 01 | Month | 23 | Day |
2013 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011537
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