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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00352534




Registration number
NCT00352534
Ethics application status
Date submitted
13/07/2006
Date registered
14/07/2006
Date last updated
15/05/2017

Titles & IDs
Public title
Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
Scientific title
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
Secondary ID [1] 0 0
NCI-2009-01067
Secondary ID [2] 0 0
AREN0532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage I Wilms Tumor 0 0
Stage II Wilms Tumor 0 0
Stage III Wilms Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - therapeutic conventional surgery
Treatment: Drugs - vincristine sulfate
Other interventions - dactinomycin
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Other - 3-dimensional conformal radiation therapy

Experimental: Nephrectomy and re-evaluation (very low-risk disease) - Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks.

Experimental: Nephrectomy, chemotherapy (standard-risk, stg I or II) - Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks.

Experimental: Nephrectomy/biopsy, chemotherapy (standard-risk, stage III) - Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks.


Treatment: Surgery: therapeutic conventional surgery
Undergo surgery

Treatment: Drugs: vincristine sulfate
Given IV

Other interventions: dactinomycin
Given IV

Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Other: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival Probability - Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Overall Survival (OS) Probability - Probability of being alive after 4 years in the study.
Timepoint [2] 0 0
4 years
Secondary outcome [1] 0 0
Incidence of Contralateral Kidney Lesions - Number of contralateral kidney lesions during follow-up.
Timepoint [1] 0 0
During follow-up
Secondary outcome [2] 0 0
Incidence of Renal Failure - Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
Timepoint [2] 0 0
During follow-up

Eligibility
Key inclusion criteria
- Histologically confirmed Wilms' tumor

- Newly diagnosed stage I-III disease

- Favorable histology

- No moderate- or high-risk Wilms' predisposition syndromes

- Must meet 1 of the following disease stratification categories:

- Very low-risk disease

- Stage I disease

- Age < 2 years

- Tumor weight < 550 g

- Regional lymph nodes histologically negative (must have been sampled)

- No pulmonary metastases on CT scan of chest

- No synchronous bilateral Wilms tumors (Stage V)

- Not predisposed to develop bilateral Wilms tumors, defined as unilateral
Wilms tumor and any of the following:

- Aniridia

- Beckwith-Wiedemann syndrome

- Simpson-Golabi-Behmel syndrome

- Denys-Drash syndrome or other associated genito-urinary anomalies

- Multicentric WT or unilateral WT with contralateral nephrogenic rest(s)
in a child < 1 year of age

- Diffuse hyperplastic perilobar nephroblastomatosis

- Standard-risk disease meeting 1 of the following criteria:

- Disease does not require radiotherapy

- LOH at chromosomes 1p and 16q for stage I or II

- Stage I disease meeting 1 of the following criteria:

- Age = 2 years to age < 30 years

- Tumor weight = 500 g

- Stage II disease

- Age < 30 years

- Any tumor weight

- Disease requires radiotherapy

- No LOH at chromosomes 1p and 16q*

- Stage III disease

- Must be enrolled on protocol COG-AREN03B2

- Karnofsky performance status (PS) 50-100% for patients > 16 years old

- Lansky PS 50-100% for patients = 16 years old

- Bilirubin (direct) = 1.5 times upper limit of normal (ULN)

- AST or ALT < 2.5 times ULN

- Shortening fraction = 27% by echocardiogram OR ejection fraction = 50% by radionuclide
angiogram (standard-risk disease)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patient must use effective contraception

- No prior tumor-directed chemotherapy or radiotherapy

- Patients transferring from AREN03B2 with LOH 1p and 16q allowed
Minimum age
No limit
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Childrens Hospital - Herston
Recruitment hospital [5] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6008 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Mississippi
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Nebraska
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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West Virginia
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Wisconsin
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Alberta
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British Columbia
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Manitoba
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Quebec
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Saskatchewan
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Israel
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Petah Tikua
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Auckland
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New Zealand
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Christchurch
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San Juan
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Switzerland
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Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without
radiation therapy or observation only to see how well they work in treating patients
undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs
used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these
treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after
surgery, the tumor may not need additional treatment until it progresses. In this case,
observation may be sufficient.
Trial website
https://clinicaltrials.gov/show/NCT00352534
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Conrad Fernandez, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications