nephroblastoma
Conditions
Interventions
Chemotherapy regimen DD-4A using actinomycin D (ACD), vincristine (VCR) and are administered for 6 or 12 weeks. ACD iv for 0.045 mg/kg on week 1, 7, 13, 19 and 25. VCR iv for 0.05mg/kg is started
Sponsors
Japan Children's Cancer Group(JCCG) (Japan Wilms Tumor Study Group, JWiTS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Radiologicaly confirmed bilateral nephroblastoma. If pathological diagnosis is different, the patient will be excluded after surgery. 2) Age < 18 years 3) No previous chemotherapy, radiotherapy or surgery 4) Written informed consent and national/local ethics committee and regulatory approval 5) Ability to comply with requirements for submission of material for central review (radiology, and pathology)
Exclusion criteria
Exclusion criteria: Cases with one of the following factors 1)Recurrent disease 2)Active double cancer, synchronous or remission less than 5 years 3)Performance Status (ECOG/Zubrod Score) is 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) 4)Severe organ failure (hematologic, liver, kidney, heart) White blood cells < 2000/mm3 Platelets <100,000/mm3 Serum bilirubin > 2.5 x normal limit Serum ALT > 2.5 x normal limit Serum total bile acid > 2.5 x normal limit Serum creatinine > 2.5 x normal limit 5) Patient unable to undergo chemotherapy due to other disease, or the attending doctor considers inappropriate to entry this study. 6)The patient has a psychological disorder so that unable for entry. 7)Patient unable to tolerate the chemotherapy for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of the bilateral renal preservation at 1 year after registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, disease free survival, recurrence rate, disease specific survival Rate of hemilateral/bilateral nephrectomy Rate of renal dysfunction Rate of renal failure Rate of toxicities Evaluation of pathological findings after chemotherapy by JWiTS specified pathologists Response rate to neo-adjuvant chemotherapy evaluated by the specified radiologists. | — |
Countries
Japan
Contacts
Public ContactTakaharu Oue
Hyogo College of Medicine Pediatric Surgery
Outcome results
None listed