Download Protocol Summary National Wilms Tumor Study Group

Protocol Summary
National Wilms Tumor Study Group
(NWTS)
Patty Sponseller, CMD
DOS741 Protocols and
Studies in Radiation
Oncology 2011
History
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Established 1969
Brought together investigators already
participating in cooperative groups
Founding Chairman, Dr. Guilio D’ Angio
Vision cure childhood cancers, particularly
Wilms tumor
History of NWTS
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Established in 1969
Original Institutions from Children’s Cancer Group and Pediatric
Division of SWOG and CALBG
In 2001 NWTSG and Intergroup Rhabdomyosarcoma Study
Group to form new organization Children’s Oncology Group
(COG)
Patient entry in NWTSG ended in 2002
Subsequent and future trials for children with renal tumors are
conducted by COG
NWTS is still a destination used only for studying late effects of
patients originally enrolled
http://www.nwtsg.org
Combined Efforts
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Only 500 cases diagnosed annually
Single or small groups of institutions not
enough patients to study
Investigators and Institutions agreed to
combine efforts
Goal was to get answers in a short period of
time
Vision
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Survivors could lead normal adult lives
Free of late effects caused by treatment
NWTS pioneer in multi-modal treatment
Included all professions as full members
Goals
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Improve survival
Children with Wilms tumors or other renal
tumors
Study long-term outcomes
Study epidemiology and biology of Wilms
tumors
Make this information available world wide
How would these children benefit?
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Investigators wanted answers to long
standing therapy ?’s
Determine risks
Gauge outcomes
Results – better treatment
NWTS Trials
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Conducted 5 trials
Determine which drugs or combinations
Decrease the radiation dose
Enrolled more than 400 children/year
70% of Wilms Tumor patients in United
States
33 year span
Control
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Each study identified objectives which
included the original objectives
New study built on results of previous study
Resulted in improvements
1st trial already showed diminished late
effects
NWTS-1
October 1969 to February 1975
 Accrued 741 patients
 Results –
No RT to low risk Group I
Drug combinations more effective
Favorable and unfavorable histologic
classifications
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NWTS-2
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January 1975 to April 1979
Accrued 950 patients
Results –
Group I treated for 6 months
ADR improved outcomes for Groups I & II
Chemotherapy doses for babies
Prognosis for favorable and unfavorable
Grouping redefined and new staging
NWTS-3
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May 1979 to September 1986
Accrued 2496 patients
Results –
Patients divided into 2 Groups
Stage I FH or focal anaplasia no RT
Stage III FH best with 3 drugs
Stage III-IV 4 drugs
NWTS-4
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August 1986 to August 1995
Accrued 3335 patients
Results –
“pulse intensive” drug doses
Cost of therapy decreased
NWTS-5
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August 1995 to May 2002
Accrued 3031 patients
Results –
Chromosomes tagged to outcome
Surgery alone adequate
Patients with pulmonary mets may benefit with
doxorubicin
Results Radiotherapy Regiment
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Patients are treated on COG study
Result of 5 trials dropped (FH) dose to
abdomen to 1080 cGy and 1200 cGy whole
lung
Post-op RT start 14 days after surgery
RT limited to Stages III and IV only
Stage IV (FH) with pulmonary nodules after
RT receive whole lung RT
Present Day
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Late effects study
Includes only those enrolled in one of the
original NWTS trials
Determines risks and mortality rates
Contributions to genetic epidemiology
Eligibility
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Participants must have been consented for
one of the original trials
Participant must have been registered
All trial data was submitted to NWTS
Tissue sent to central Pathology of NWTS
Diagnosis Wilms, clear cell sarcoma of
kidney or rhabdoid tumor of kidney
Success
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Answers to long standing ?’s in a short time
frame
Accomplished by a multi-modal group
Careful data collection and follow up
Research continues to lead to improvements
Now carried out by COG