Dettagli per singolo studio

DEC-NET Serial number GB480

Published online	19/09/2005 17.26.00
Last updated	20/09/2005 11.36.40

Other protocol ID number	WT 2002 01
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	03/2002 350
Major Disease (ICD9 class)	MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS
Experimental drug
Carboplatin Treatment regimen (dosage and duration) 22mg/m2 daily x2 intravenously for 3 days, repeated every 21 days for 8 courses
Etoposide Treatment regimen (dosage and duration) 150mg/m2 daily x3 intravenously for 3 days, repeated every 21 days for 8 courses in total
Control drug
Doxorubicin Treatment regimen (dosage and duration) Not given
Actinomycin D Treatment regimen (dosage and duration) not given
Vincristine Treatment regimen (dosage and duration) not given
CYCLOPHOSPHAMIDE Treatment regimen (dosage and duration) Not given
Gender	Both
Age (range)	6 months to 18 years
Eligibility criteria
Inclusion criteria
Wilms tumour or other renal tumour of childhood
Exclusion criteria
Patients that do not fulfil the eligibility criteria
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised
Purpose of study
To continue a risk-adapted stratification of therapeutic intensity, incorporating response to pre-operative chemotherapy, in all children with wilms tumour and other renal tumors of childhood
Primary outcomes
The trial should provide evidence for the need for anthracyclines in the treatment of Wilms tumour A 2 year event free survival (EFS) an event being a patient's relapse or death from any cause.
Secondary outcomes
Prospective data on the prognostic value of other biological factors and histological subgroups
Summary of study design, objectives, and ongoing research findings
Randomised test intervention (A: post-operative treatment with 3 drugs, B: reduced treatment with 2 drugs) versus standardised intervention, non-blinded. All patients aged 6 months to 18 years with a diagnosis of non-metastic primary intrarenal tumour will undergo biopsy followed by neoadjuvant chemotherapy. Tumor volume will be documented prior to delayed nephrectomy at week 5. Post-operative chemotherapy will be stratified according to tumour stage and histological subtype. Patient with stage 11/111 tumours of intermediate risk histological subtype (i.e. lacking anaplasia, blastemal predominance or total necrosis) will be randomised to receive a total of 26 weeks chemotherapy with or without doxorubicin at a total dose of 250mg/m2. The trial should provide evidence for the need for anthracyclines in the treatment of Wilms tumour. Patients with localized disease receive neoadjuvant therapy comprising vincristine IV on days 1, 8, 15, and 22 and dactinomycin IV on days 1 and 15. Patients undergo surgery during weeks 5 or 6. Patients with low-risk stage I disease receive no further therapy. Adjuvant chemotherapy begins after surgery and within 21 days of last dose of neoadjuvant chemotherapy. Patients with intermediate-risk stage I disease receive vincristine IV on days 1, 8, 15, and 22 and dactinomycin IV on day 7. Patients with intermediate-risk stage II or III disease are randomized to 1 of 2 treatment arms. Arm I: Patients receive vincristine IV weekly for 8 weeks and then on days 1 and 7 of weeks 11, 14, 17, 20, 23, and 26. Patients also receive dactinomycin IV weekly on weeks 2, 5, 8, 11, 14, 17, 20, 23, and 26 and doxorubicin IV over 4-6 hours weekly on weeks 2, 8, 14, 20, and 26. Arm II: Patients receive vincristine and dactinomycin as in arm I. Patients with high-risk stage I disease receive chemotherapy as in arm I. Patients with low-risk stage II disease receive chemotherapy as in arm II. Patients with high-risk stage II or III disease receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 on weeks 1, 7, 13, 19, 25, and 31. Patients also receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 on weeks 4, 10, 16, 22, 28, and 34. Patients with intermediate-risk stage III or high-risk stage II or III disease also undergo radiotherapy for approximately 3 weeks during chemotherapy. Patients with metastatic disease receive neoadjuvant chemotherapy comprising vincristine IV on day 1 of weeks 1-6, dactinomycin IV on day 1 of weeks 1, 3, and 5, and doxorubicin IV over 4-6 hours on day 1 of weeks 1 and 5. Patients undergo surgery during week 7. Within 2 weeks of surgery patients receive 1 of the following adjuvant chemotherapy regimens: Regimen A (no metastases or completely resected): Patients receive vincristine IV weekly for 8 weeks and then on weeks 11, 12, 14, 15, 17, 18, 20, 21, 23, 24, 26, and 27. Patients also receive dactinomycin IV on day 1 of weeks 2, 5, 8, 11, 14, 17, 20, 23, and 26 and doxorubicin IV over 4-6 hours on weeks 2, 8, 14, and 20. Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks. Regimen B (multiple inoperable metastases, incomplete resection, or high-risk primary disease): Patients receive etoposide IV over 4 hours and carboplatin IV over 1 hour on days 1-3 of weeks 4, 10, 13, 16, 22, 25, 28, and 34. Patients also receive cyclophosphamide IV over 1 hour on days 1-3 and doxorubicin IV over 4-6 hours on day 1 of weeks 1, 7, 19, and 31. Some patients also undergo radiotherapy concurrently with chemotherapy for approximately 3 weeks. Patients are followed every 2-3 months for 2 years, every 3-6 months for 1-2 years, and then every 6-12 months thereafter.