Unique ID issued by UMIN | UMIN000003002 |
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Receipt number | R000003638 |
Scientific Title | Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults |
Date of disclosure of the study information | 2010/01/09 |
Last modified on | 2015/01/09 13:28:00 |
Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults
Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors
Randomized phase II study of two cross-over sequences comprising outpatient chemotherapies, vinorelbine/cyclophosphamide (R1) and temozolomide/etoposide (R2), for relapsed or refractory solid tumors in children and young adults
Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors
Japan |
Relapse or refractory pediatric solid tumor
Pediatrics |
Malignancy
NO
1. To examine safety and efficacy of weekly vinorelbine (VNR) with daily oral cyclophosphamide (CY)
3. To determine the safety and efficacy of the oral combination chemotherapy comprising temozolomide (TMZ) and etoposide (VP)
3. To explore which regimen between VNR+CY and TMZ+VP be preferable as starting one for survival in outpatient palliative setting for children and young adults with solid tumors refractory to any therapies with labeled drugs in Japan
Efficacy
Exploratory
Pragmatic
Phase II
Overall survival
Progression free survival (per regimen or per whole protocol therapy), time to treatment failure (1st regimen or whole protocol therapy), response rate, Adverse events profile, self-reported QOL with face scale, number of days attending school/workplace, number of days not attending hospital
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
VNR+CY: weekly intravenous VNR day1,8,15 with daily oral CY, to be repeated every 4 weeks
TMZ+VP: 5 day schedule oral TMZ and 12 day schedule oral VP, to be repeated every 4 weeks
3 | years-old | <= |
30 | years-old | >= |
Male and Female
1. neuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, retinoblastoma, Wilm's tumor, hepatoblastoma, osteosarcoma, other bone or soft tissue sarcoma, primary CNS tumors, germ cell tumors
2. relapse or progression following disease-specific standard chemotherapies
3. evidence of progression in clinical signs or symptoms, of bone marrow metastasis, or of progression or stable disease on imaging studies
4. no prior chemotherapy containing either vinorelbine or temozolomide
5. > 28 days since prior nitrosourea or > 14 days since prior other antitumor cytotoxic agents
6. > 14 days since prior palliative radiation therapy (irradiation dose is less than or equal to 30 Gy) or > 21 days since prior non-palliative irradiation
7. > 14 days since prior surgery (including open biopsy)
8. 0-2 in ECOG PS
9. confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 5,000/mm~3 (at least 3days since prior concentrated platelet transfusion)
(3) serum total Bilirubin <= 1.2mg/dl
(4) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])
10. no difficulty to take 8mm tablet
11. legal adult: Written informed consent
12. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian
13. 15 years and under: written informed consent from legal guardian
1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
2. Active infection requiring systemic medication
3. abnormality in electrocardiogram tested within 28 days, requiring intervention
4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
5. Women during pregnancy or breast-feeding
7. Psychosis
45
1st name | |
Middle name | |
Last name | Atsushi Ogawa |
Niigata Cancer Center Hospital
Pediatric Devision
2-15-3 Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan
025-266-5111
atsushi@niigata-cc.jp
1st name | |
Middle name | |
Last name | Atsushi Ogawa |
study coordinator
Niigata Cancer Center Hospital pediatric division
15-3, kawagishicho 2chome, Chuo-ku, Niigata 951-8566, Japan
025-266-5111
http://www.nposuccess.jp/datacenter/
atsushi@niigata-cc.jp
Group for " Cross-over rPII of outpatient chemotherapies for refractory pediatric solid tumors "
Ministry of Health, Labour and Welfare
Japan
NO
国立がん研究センター中央病院(東京都)
国立がん研究センター東病院(茨城)
日本大学医学部附属板橋病院(東京都)
埼玉県立小児医療センター(埼玉県)
国立がんセンター東病院(千葉県)
静岡県立静岡がんセンター(静岡県)
新潟県立がんセンター新潟病院(新潟県)
大阪市立総合医療センター(大阪府)
滋賀医科大学附属病院(滋賀県)
鹿児島大学医学部附属病院(鹿児島県)
愛知県がんセンター中央病院(愛知県)
兵庫県立こども病院(兵庫県)
福島県立医科大学付属病院(福島県)
2010 | Year | 01 | Month | 09 | Day |
Partially published
No longer recruiting
2009 | Year | 12 | Month | 17 | Day |
2010 | Year | 01 | Month | 01 | Day |
2014 | Year | 05 | Month | 30 | Day |
2010 | Year | 01 | Month | 09 | Day |
2015 | Year | 01 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003638
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